Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2124215

FEI Number

2124215

Entity Name

Boston Scientific Corporation

City/State/Country

Saint Paul, MN, US

Establishment Address

4100 Hamline Ave N, Saint Paul, MN 55112, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Boston Scientific Corporation (Owner Number: 9912058)

Owner / Operator Contact Address

300 Boston Scientific Way, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K051399

PMA Number

N/A

All Registered Proprietary Names

SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System EMBLEM S-ICD Subcutaneous Electrode EMBLEM S-ICD Electrode EMBLEM S-ICD Programmer EMBLEM S-ICD Pulse Generator EMBLEM MRI S-ICD Subcutaneous Implantable Cardioverter Defibrillator EMBLEM S-ICD Electrode Delivery System EMBLEM S-ICD Electrode Insertion System EMBLEM S-ICD Subcutaneous Implantable Cardioverter Defibrillator EMBLEM S-ICD System Patient Screen Tool Log Data Card for the Model 3200 EMBLEM S-ICD Programmer Power Supply for S-ICD Programmer Tool Wand for SICD Programmer 3200 SQ-RX Pulse Generator AGENT Paclitaxel-Coated Balloon Catheter Ambicor AMS 700 with Inhibizone AMS 700 without Inhibizone Carotid WALLSTENT Monorail Endoprosthesis Epic Vascular Self-Expanding Stent System Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device Flextome Cutting Balloon Microsurgical Dilatation Device Apex Push PTCA Dilatation Catheter Apex PTCA Dilatation Catheter Express SD Renal/Biliary Premounted Stent System AngioJet Ultra 5000A Console AngioJet Spiroflex Thrombecotmy Set AngioJet Spiroflex VG Thrombectomy Set AutoElite Thrombectomy System Console INTELLAGEN Remote Control Connection Cable 30 Meter Cable IntellaTip MiFi XP Sterile Cable IntellaTip MiFi Reference Cable Non-Sterile Electrophysiology Cable IntellaTip MiFi Filter Module RF Frequency Filter IntellaTip MiFi XP Temperature Ablation Catheter Blazer Prime XP Temperature Ablation Catheter IntellaNav MiFi XP Temperature Ablation Catheter Electrophysiology Cable Non-Sterile Cable Blazer Solid-Tip Ablation Cather Cable, Sterile Cable Maestro 4000 RF Cardiac Ablation Controller Maestro 4000 RF Cardiac Ablation Pod 100 Maestro Foot Switch IntellaNav XP Temperature Ablation Catheter Maestro 4000 Remote Control Cable, IntellaNav Ablation Catheter Rhythmia Mapping System IntellaNav CB - Maestro Rhythmia HDx Ablation Connection Box Blazer II XP Temperature Ablation Catheter INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Grounding Cable 3 Meter Non-Sterile Cable INTELLAGEN RF Generator Kit INTELLAGEN Remote Control Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 25 Meter INTELLAGEN Foot Pedal Extension Cable 7 Meter INTELLAGEN Foot Pedal INTELLAGEN Remote Control Kit INTELLAGEN ECG Connection Cable 3 Meter INTELLAGEN Serial Communication Cable 3 Meter INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Remote Control Connection Cable 15 Meter Rhythmia HDx Ablation Connection Box - for INTELLAGEN Stylet INGEVITY MRI FORMIO MRI VITALIO MRI INGENIO MRI Suture Sleeve ESSENTIO MRI PROPONENT MRI ACCOLADE MRI Urovac Bladder Evacuator Precision Battery AAA 1.5 Alkaline Precision Charger Artisan Surgical Lead Kit Cable, USB Serial Precision Spectra Patient Trial Belt Precision Lead Blank O.R. Cable and Extension Precision Spectra External Trial Stimulator Precision AC/DC Power Supply Charger Belt Extension Precision Precision Spectra Remote Control Enhanced Steering Kit with Stylet Cap Introducer Remote Control Silicone Case Clik X MRI Anchor D4 Splitter Kit Spectra WaveWriter Implantable Pulse Generator and Charging Kit Precision Patient Trial Belt Linear 3-6 Lead Kit USB Splitter Power Unlimited, Power Adapter Precision Implantable Pulse Generator and Charging Kit Precision Adhesive Kit Clik X Anchor Precision Novi Implantable Pulse Generator Kit Precision IPG Port Plug Precision Lithium Manganese Dioxide Battery 6 Volts Precision Cable, USB-Serial Patient Trial Kit Linear 3-4 Lead Kit Spectra WaveWriter External Trial Stimulator Precision IRDA Dongle Holder Charger Spacer Precision Spectra IPG Port Plug Precision Patient Trial Kit Tablet Pen Charger Belt Loops Replacement Paddle Blank for CoverEdge 32 Surgical Lead Precision Connector Clinician Programmer Insertion Needle Precision OMG Connector-A Precision Primary Lithium Battery AA Type STD Precision Charging System Kit Precision Base Station Precision External Trial Stimulator Linear Precision Tablet PC Pen Spectra Implantable Pulse Generator and Charging Kit CoverEdge X 32 Surgical Lead Kit Splitter Kit Precision Passing Elevator Programming Wand Spectra Implantable Pulse Generator Kit Charger Belt Precision Epimed Needle Clik Anchor Hex Wrench Medical Adhesive Precision PC SC-7150 CoverEdge 32 Surgical Lead Kit Installer for BN3.1 Entrada Needle Precision Suture Sleeve Precision Remote Control Case Precision Charging Belt Precision Patient Controller Entrada Spare Sheath Precision Hex Wrench Precision S8 Adapter Precision OMG Connector-M Power Supply for Tablet Computer USB Power Supply Remote Control (U.S.) Precision Power Supply & Adapter For Charger Precision Clinician Programmer Stylet Kit with Stylet Cap Precision Spectra OMG Adapter Extension Kit Precision Montage MRI Implantable Pulse Generator Kit Precision Patient Programmer Kit Infinion Lead Kit W4 Splitter Kit Precision Holster Click Anchor Spectra External Trial Stimulator Linear ST Lead Kit Avista MRI Lead Kit Infinion CX Lead Kit Tunneling Tool SCS Implantable Materials Kit Linear Lead Kit Precision Spectra Remote Control Kit Spectra WaveWriter Implantable Pulse Generator Precision Spectra Implantable Pulse Generator Kit Paddle Blank for CoverEdge X 32 Surgical Lead Remote Control Holster Precision Implantable Pulse Generator Kit Precision Remote Control Artisan MRI Surgical Lead Kit Bionic Navigator 3D Installer Keyboard Precision Spectra Implantable Pulse Generator and Charging Kit Precision Spectra Patient Trial Kit Precision IR Interface Precision Montage MRI Implantable Pulse Generator and Charging Kit Precision Montage Implantable Pulse Generator Kit Precision M8 Adapter WaveWriter Alpha 16 IPG and Charging Kit CoverEdge X MRI 4x8 Surgical Lead Kit WaveWriter Alpha IPG and Charging Kit Pairing Magnet WaveWriter Alpha ETS Bionic Navigator 3D 4 Installer Freelink Remote Control WaveWriter Alpha IPG Kit CoverEdge MRI 4x8 Surgical Lead Kit WaveWriter Alpha ETS Trial Belt Freelink Remote Control Kit WaveWriter Alpha Prime IPG Kit WaveWriter Alpha 16 IPG Kit WaveWriter Alpha Patient Trial Kit Bionic Navigator Installer WaveWriter Alpha Prime 16 IPG Kit Bionic Navigator 3D 4.1 Installer mySCS GO Therapy Controller Clinician Kit mySCS GO Therapy Controller App Infinion Pro Lead Kit mySCS GO Therapy Controller Patient Kit mySCS GO Therapy Controller App Patient Literature Kit Ranger Paclitaxel-Coated PTA Balloon Catheter Bulkamid Urethral Bulking System ACUITY Spiral Bi Directional Torque Wrench INOGEN CRT-D DYNAGEN CRT-D INOGEN X4 CRT-D DYNAGEN X4 CRT-D ACUITY X4 Spiral CONTAK RENEWAL AVT Software CONTAK RENEWAL Software Application ACUITY X4 Straight ACUITY X4 Flushing Tool/Wire Guide CONTAK CD Software Application VIGILIANT X4 CRT-D VIGILIANT CRT-D AUTOGEN X4 CRT-D MOMENTUM X4 CRT-D RESONATE X4 CRT-D MOMENTUM CRT-D RESONATE HF CRT-D RESONATE CRT-D CONTAK CD2 Software Application AUTOGEN CRT-D ENERGEN CRT-D Suture Sleeve INCEPTA CRT-D Lead Cap EASYTRAK 3 EASYTRAK 3 IS-1 PUNCTUA CRT-D EASYTRAK 2 IS-1 EASYTRAK 2 Magnet Lead Stabilizer Kit Anchor Sleeve Lead Tunneler Kit Lead Cap Kit Model 1550 AICD Software Module Medical Adhesive Mineral Oil Lead Stylet Vein Pick J Shaped Lead Stylet Straight Lead Stylet FINELINE II Sterox FINELINE II EZ Sterox Suture Sleeves Express LD Iliac/Biliary Stent System ENROUTE Transcarotid Stent System Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System AMS 800 with Inhibizone AMS 800 without Inhibizone WALLSTENT RP Endoprosthesis Self-Expanding Stent WALLSTENT Endoprosthesis Self-Expanding Stent SMARTFREEZE Cryo-Cable SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Console SMARTFREEZE Inter-Connection Box SMARTFREEZE Cryo-Console Foot Switch POLARx Cryoablation Balloon Catheter SMARTFREEZE Remote Control POLARx FIT Cryoablation Balloon Catheter SMARTFREEZE Diaphragm Movement Sensor FLEXTEND Lead Stabilizer Kit Fixation Tool Electrophysiology Cable Sterile Cable Maestro 4000 Controller, RF Cardiac Ablation Controller Blazer Prime HTD Temperature Ablation Catheter Maestro 4000 Remote Control Maestro 4000 Pod, 100W, RF Cardiac Ablation Pod, 100W Maestro Foot Switch IntellaNav ST Ablation Catheter Blazer II HTD Temperature Ablation Catheter Cable, IntellaNav Ablation Catheter Blazer II Temperature Ablation Catheter INTELLAGEN Foot Pedal INTELLAGEN Remote Control Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 25 Meter INTELLAGEN Grounding Cable 3 Meter Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Remote Control Connection Cable 30 Meter Maestro Remote Control Cable Non-Sterile Cable (Controller to Pump or Remote Control) INTELLAGEN Serial Communication Cable 3 Meter Rhythmia HDx Ablation Connection Box - for INTELLAGEN INTELLAGEN Remote Control Kit INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Remote Control Connection Cable 15 Meter INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN RF Generator Kit INTELLAGEN Foot Pedal Extension Cable 7 Meter INTELLAGEN ECG Connection Cable 3 Meter LATITUDE Clarity myLUX LUX-Dx Axonics Rechargeable Sacral Neuromodulation System Axonics SNM Therapy Foramen Finder Axonics SNM System Axonics Sacral Neuromodulation System Axonics r-SNM System Axonics System Axonics Axonics Therapy for Bowel Control Axonics Therapy Axonics Sacral Neuromodulation Therapy Colpassist Vaginal Positioning Device FARASTAR IEC Recording System Module ECG Output Module FARASTAR Stimulation Module Male Cable FARASTAR IEC Recording System Module ECG Trunk Cable FARASTAR AAMI Recoding System Module ECG Output Module FARASTAR AAMI Snap Cable R/L FARASTAR Recording System Module FARASTAR Catheter Connection Cable FARASTAR IEC Snap Cable C Set FARAWAVE Pulsed Field Ablation Catheter FARASTAR Mapping System Module FARASTAR Stimulation Module Cable FARASTAR Stimulation Module Y-Cable Short FARASTAR Stimulation Module Y-Cable Long FARASTAR Cable Set FARAWAVE Nav Pulsed Field Ablation Catheter FARASTAR Mapping System Module BNC-Phono Cable FARASTAR EGM Cable FARASTAR Mapping System Module Back Patch Cable Male FARASTAR Gen 2 Catheter Connection Cable FARASTAR Recording System Module ECG Output to Signal Station ECG Input Cable FARASTAR to OPAL HDx FARASTAR Stimulation Module Female Cable FARASTAR Inter-Connection Box FARASTAR EGM to EP Recording System Cable (FARAPOINT) FARASTAR Mapping System Module Auxiliary Cable FARASTAR AAMI Snap Cable V Set FARASTAR Mapping System Module Back Patch Cable FARASTAR Pulsed Field Ablation Generator FARASTAR IEC Snap Cable R/L FARASTAR Mapping System Module ABL Output to Signal Station ABL Input Cable FARASTAR to OPAL HDx FARASTAR AAMI Recording System Module ECG Trunk Cable FARASTAR Recording System Module EGM Input Module FARASTAR Recording System Module Catheter Pin Cable FARAPOINT Pulsed Field Ablation Catheter FARASTAR Recording System Module EGM Output to Singal Station EGM Input Cable FARASTAR to OPAL HDx DYNAGEN MINI INOGEN EL DYNAGEN EL VIGILIANT EL ICD INOGEN MINI PERCIVA HF ICD AUTOGEN EL PERCIVA ICD RESONATE HF ICD MOMENTUM EL ICD RESONATE EL ICD PUNCTUA INCEPTA ENERGEN Ureteral Stent Positioners FORMIO VITALIO ESSENTIO ACCOLADE PROPONENT ALTRUA 2 Screw Cap Wrench ALTRUA 60 INGENIO ALTRUA 40 ADVANTIO ALTRUA 20 WALLSTENT Endoprosthesis Self-Expanding Stent WALLSTENT RP Endoprosthesis Self-Expanding Stent VENOUS WALLSTENT Self-Expanding Stent WALLSTENT RP Endoprosthesis Self-Expanding Stent ELUVIA Drug-Eluting Vascular Stent System INTUA VALITUDE VALITUDE X4 VISIONIST X4 VISIONIST INVIVE CONTAK RENEWAL TR Software Application Flexima Nephrostomy Catheter System Kit Flexima Nephrostomy Catheter System TLA Introducer Needle and Sheath Set Percutaneous Access Needle Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit Malecot Nephrostomy Catheter Set Flexima Nephrostomy Catheter System Kit with Dissolving Tip Flexima Nephrostomy Catheter System with Dissolving Tip JINRO Pigtail Nephrostomy Catheter Kit Percuflex Locking Loop Nephrostomy Catheter with Fader Tip Re-entry Malecot Nephrostomy Catheter Set Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Percutaneous Access Needle with Echogenic Tip JINRO Pigtail Nephrostomy Catheter Placement Kit JINRO Pigtail Nephrostomy Catheter Percuflex Locking Loop Nephrostomy Catheter VTC Nephrostomy Catheters System Kit VTC Nephrostomy Catheters System Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit Percutaneous Access Set NaviGuide Percutaneous Access Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-10-08
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2024-10-08
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2015-10-05
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2012-10-07
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2012-10-07
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2019-10-11
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	Class 1	876.1075	2004-09-13
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	1992-07-22
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-09-20
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-03-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-09-16
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-10-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-05-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-10-25
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-10-14
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-04-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-02-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-02-28
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2010-10-28
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2014-10-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-02-05
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-08-06
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2013-12-17
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2007-05-10
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	1992-08-27
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2016-12-15
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-01-08
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-11-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-04-04
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2023-07-15
OOB	Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	Unknown	Class 3	N/A	2024-03-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-10-06
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-03
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2015-07-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-01-11
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-06-12
DXK	Echocardiograph	Cardiovascular	Class 2	870.2330	2018-06-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-07-18
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-10-11
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2019-10-11
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2021-09-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-01-10
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2024-03-25
FHW	Device, Impotence, Mechanical/Hydraulic	Gastroenterology, Urology	Class 3	876.3350	2015-10-06
JCW	Prosthesis, Penis, Inflatable	Gastroenterology, Urology	Class 3	876.3350	2015-10-06
NIM	Stent, Carotid	Unknown	Class 3	N/A	2008-12-24
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2022-03-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-03-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-03-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-08-24
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2014-10-29
OTO	Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2013-03-17
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-01
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2022-03-14
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-03-30
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2021-03-16
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2014-09-26
NIO	Stent, Iliac	Unknown	Class 3	N/A	2012-12-13
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-10-08
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2000-05-18
MAF	Stent, Coronary	Unknown	Class 3	N/A	2000-05-18
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2000-05-18
NWX	Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	Unknown	Class 3	N/A	2000-05-18
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2000-05-18
NIN	Stent, Renal	Unknown	Class 3	N/A	2000-05-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-11-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-11-01
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-10-08
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2016-05-31
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-08-15
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2011-08-15
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2017-01-26
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2024-09-16
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2008-01-22
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2014-11-10
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2018-05-24
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2022-03-29
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2013-12-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-01-10
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2017-10-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2016-02-16
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2022-03-14
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-11-25
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2019-10-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-10-11
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2022-03-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-03-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-03-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-01-11
NIN	Stent, Renal	Unknown	Class 3	N/A	2008-12-23
MCX	Catheter, Coronary, Atherectomy	Unknown	Class 3	N/A	2014-10-29
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-10-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-07-19
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2014-07-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2005-08-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-03
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2008-01-14
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-01-14
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2008-01-03
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2026-03-17
GCE	Adaptor, Catheter	General, Plastic Surgery	Class 1	878.4200	1993-01-01
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-10-06
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2016-04-25
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2016-04-25
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2024-09-20
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2016-12-05
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2011-12-12
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2011-12-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-03-19
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	1992-07-22
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-01-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2026-01-15
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2013-03-05
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2013-03-05
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2007-11-19
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2007-11-19
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2022-02-03
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2022-02-03
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2016-08-25
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2022-03-14
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2023-08-03
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-03-14
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2025-09-30
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2025-02-21
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2019-10-11
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2025-12-05
PIJ	Collagen Surgical Mesh Containing Drugs	General, Plastic Surgery	Class 2	878.3300	2025-12-05
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2025-12-05
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2025-12-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-10
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2023-11-15
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2012-12-13
FFA	Tube, Drainage, Suprapubic	Gastroenterology, Urology	Class 2	876.5090	2008-01-03
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2008-01-03
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-03
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2020-03-30
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	1983-09-09
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2024-06-03
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2002-01-15
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2025-07-11
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2025-07-11
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2025-07-11
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2014-10-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2012-12-11
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-09-20
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2014-10-29
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2008-01-03
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2013-06-04
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2012-01-06
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-10
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2008-01-14
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2013-12-16
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2020-11-02
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown	Class 3	N/A	2024-12-11
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2014-07-22
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-08-14
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-01-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-10-21
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-03-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-10-08
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-10-06
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2013-08-02
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-09-27
DTC	Analyzer, Pacemaker Generator Function	Cardiovascular	Class 2	870.3630	2017-09-12
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2010-10-26
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2010-10-26
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2010-10-26
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2010-10-26
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2010-10-26
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-04-25
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2018-04-25
NOY	Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	Class 2	876.5550	2018-04-25
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2010-10-26
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2010-10-26
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2014-09-19
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2022-04-26
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2022-04-26
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-03-06
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-03-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-03-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-14
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2010-10-28
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2010-10-28
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2010-10-28
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2010-10-28
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1997-10-20
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	General, Plastic Surgery	Class 2	878.3300	2018-11-28
NIO	Stent, Iliac	Unknown	Class 3	N/A	2010-12-07
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-01-23
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2019-08-06
NIM	Stent, Carotid	Unknown	Class 3	N/A	2024-10-14
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2008-01-03
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2011-11-28
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	1996-06-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-03-14
NJE	Intracranial Neurovascular Stent	Unknown	Class f	N/A	2008-01-10
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2008-01-03
DXK	Echocardiograph	Cardiovascular	Class 2	870.2330	2016-04-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-04-14
EZY	Device, Incontinence, Mechanical/Hydraulic	Gastroenterology, Urology	Class 3	876.5280	2015-10-06
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2008-01-03
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2012-12-11
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2023-09-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-10-08
MIR	Shunt, Portosystemic, Endoprosthesis	Unknown	Class 3	N/A	2008-01-22
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1999-03-08
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2007-07-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2024-10-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-10-21
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2015-10-21
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2015-10-21
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-10-21
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-03-26
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2014-01-02
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-10
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2024-10-14
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-08-10
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-10-28
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-10-06
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2010-10-28
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2010-10-28
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2010-10-28
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2026-03-26
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-03
FFA	Tube, Drainage, Suprapubic	Gastroenterology, Urology	Class 2	876.5090	2008-01-03
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2008-01-03
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2010-10-28
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2024-09-04
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-10-08
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2020-08-03
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2020-08-03
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2021-05-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-03-06
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2013-10-28
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2010-03-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-03-25
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2014-10-29
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2014-10-29
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2025-08-28
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2026-05-12
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-05-18
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2026-05-22
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2013-07-18
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2008-01-14
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-01-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2009-12-07
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-12-13
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2016-12-20
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2020-06-29
PTL	Wire, Guide, Catheter, Exempt	Cardiovascular	Class 2	870.1330	2023-08-02
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2016-08-25
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2016-08-25
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-09-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-03-18
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-01-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-03-14
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-03-14
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2019-10-10
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2019-10-10
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	Gastroenterology, Urology	Class 3	876.5270	2024-12-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-04-24
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	1992-07-22
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2013-09-06
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2013-09-06
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2024-09-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-06-28
KOH	Instrument, Manual, General Obstetric-Gynecologic	Obstetrics/Gynecology	Class 1	884.4520	2013-05-01
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2019-08-29
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-09-27
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-09-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-09-27
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-09-27
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2018-01-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-12-07
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2015-10-13
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2015-10-13
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2019-10-11
QEY	Mechanical Thrombolysis Catheter	Cardiovascular	Class 2	870.5150	2019-10-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-09-01
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2013-11-13
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2024-01-31
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-05-01
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2020-05-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2006-09-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-05-06
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2010-10-26
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2010-10-26
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2010-10-26
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2010-10-26
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-06-28
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2021-10-04
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2021-10-04
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2021-10-04
NOY	Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	Class 2	876.5550	2021-10-04
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2008-01-03
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-11-20
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2020-07-27
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-11-01
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-10-26
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2015-10-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-04-04
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2011-01-06
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2008-01-11
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2014-11-10
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2014-10-29
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2014-10-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-03-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-08-26
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-01-11
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2003-06-23
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2018-05-24
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	General, Plastic Surgery	Class 2	878.3300	2022-03-10
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-03-27
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2022-03-21
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2026-01-06
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2026-01-06
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-03-25
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2013-12-23
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2014-10-29
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2014-10-29
PPN	Percutaneous Catheter, Ultrasound	Cardiovascular	Class 2	870.1250	2025-09-30
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-10
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2015-06-08
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2011-01-06
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2011-01-06
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2025-09-05
QKJ	Stent, Central Venous	Unknown	Class 3	N/A	2008-01-22
QAN	Stent, Iliac Vein	Unknown	Class 3	N/A	2008-01-22
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2014-04-14
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-08-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2008-01-03
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-11-19
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2016-03-24
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2014-09-05
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-10-08
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2020-09-17
OFK	Percutaneous Atrial Catheter Kit	Cardiovascular	Class 2	870.1250	2024-08-07
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-02
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2012-12-13
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-11-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-07-27
OHD	Gynecological Laparoscopic Kit	Obstetrics/Gynecology	Class 2	884.1720	2013-07-02
PAH	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	General, Plastic Surgery	Class 2	878.3300	2008-12-11
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2020-01-23
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2020-01-23
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2015-11-03
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2013-06-04
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2023-07-18
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-07-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2023-07-18
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-07-18
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2008-01-03
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2008-01-10
QGD	Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories	Gastroenterology, Urology	Class 1	876.5290	2019-07-11
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2025-01-24
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2021-02-19
NIO	Stent, Iliac	Unknown	Class 3	N/A	2008-01-22
MAF	Stent, Coronary	Unknown	Class 3	N/A	2008-01-22
MIR	Shunt, Portosystemic, Endoprosthesis	Unknown	Class 3	N/A	2008-01-22
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-09-09
PWI	Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse	Obstetrics/Gynecology	Class 2	884.4910	2018-03-09
NIU	Stent, Superficial Femoral Artery, Drug-Eluting	Unknown	Class 3	N/A	2018-09-24
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2008-08-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-10-15
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2010-10-26
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2010-10-26
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2010-10-26
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2025-08-26
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2018-09-12
GBW	Catheter, Peritoneal	General, Plastic Surgery	Class 1	878.4200	2006-03-10
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-01-09
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2012-09-24
FAE	Prosthesis, Penile	Gastroenterology, Urology	Class 2	876.3630	2019-04-19
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2017-11-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-11-14
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2005-08-01
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2024-10-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2008-01-22
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2012-09-28
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-10-11
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2008-12-11
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2014-08-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boston Scientific Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3025434462	Obsidio Inc	Maple Grove, MN, US
3005619880	Boston Scientific Corporation	Roswell, GA, US
3015425075	NALU MEDICAL	Carlsbad, CA, US
3015289131	FARAPULSE, INC.	Menlo Park, CA, US
3022298579	Boston Scientific Cardiac Diagnostic Technologies, Inc.	Arden Hills, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K951723	GE Medical Systems	GE B510 TRANSDUCER	1995-11-14
K903562	Diasonics, Inc.	CW DOPPLER 2.25 MHZ PROBE	1992-03-02
K945318	Tetra Corp.	TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA	1995-05-05
K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)	2023-12-13
K251211	ABBOTT MEDICAL	ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach	2025-05-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2007	Guidant Corporation	3	Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Z-0016-2011	Boston Scientific CRM Corp	3	Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 CONTAK RENEWAL 4/4RF Models H190, H195, H197, H199, M170, M175, M177, M179, H230, H235, H239* *Not available in the US
Z-0017-2011	Boston Scientific CRM Corp	3	Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798.
Z-0025-2014	Boston Scientific CRM Corp	3	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Z-0026-2014	Boston Scientific CRM Corp	3	Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Z-0037-2012	Boston Scientific CRM Corp	3	LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493. When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2124215. Last updated year: 2026. Please use registration number 2124215 when referencing this establishment in official correspondence.