Boston Scientific Corporation

FDA Device Registration & Listing · Coventry, RI, US · Registration 1000121056

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1000121056
FEI Number
1000121056
Entity Name
Boston Scientific Corporation
City/State/Country
Coventry, RI, US
Establishment Address
8 Industrial Dr, Coventry, RI 02816, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Boston Scientific Corporation (Owner Number: 9912058)
Owner / Operator Contact Address
300 Boston Scientific Way, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device Rotaglide Lubricant Rotablator Dynaglide Foot Pedal wireClip Torquer ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device ROTAPRO Advancer Burr Advancing Device ROTAPRO Rotational Atherectomy System Console Kit ROTAWIRE Drive and wireClip Torquer Floppy RotaWire and wireClip Torquer Extra Support RotaLink Advancer Catheter Advancing Device RotaWire and wireClip Torquer Floppy Rotablator Rotational Atherectomy System Console Kit RotaLink Burr Exchangeable Burr Catheter ROTAWIRE Drive and wireClip Torquer Extra Support 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 ENDOTAK RELIANCE G Connector Tools Lead Repair Kit Lead Pulling Tip RELIANCE 4-FRONT Defibrillation Lead Suture Sleeve Accessory Lead Stylets Lead Adapter Lead Cap Kit ENDOTAK RELIANCE ENDOTAK RELIANCE SG ENDOTAK RELIANCE S 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 WALLSTENT RP Endoprosthesis Self-Expanding Stent WALLSTENT Endoprosthesis Self-Expanding Stent Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device Flextome Cutting Balloon Microsurgical Dilatation Device Epic Vascular Self-Expanding Stent System 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 WALLSTENT RP Endoprosthesis Self-Expanding Stent Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System Endovive Securi-T Percutaneous Replacement Gastrostomy Tube 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 Trapezoid RX Wireguided Retrieval Basket AngioJet Ultra 5000A Console AngioJet Spiroflex Thrombecotmy Set AngioJet Spiroflex VG Thrombectomy Set AutoElite Thrombectomy System Console Innova Vascular Self-Expanding Stent System Ranger Paclitaxel-Coated PTA Balloon Catheter ELUVIA Drug-Eluting Vascular Stent System Express SD Renal/Biliary Premounted Stent System 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 Cable, Maestro 4000 Blazer Open-Irrigated Ablation Catheter MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set MetriQ Foot Switch MetriQ Pump Irrigation Pump IntellaNav Open-Irrigated Ablation Catheter IntellaTip MiFi Open-Irrigated Ablation Catheter IntellaNav MiFi Open-Irrigated Ablation Catheter Rhythmia Mapping System IntellaNav CB - Maestro Rhythmia HDx Ablation Connection Box Maestro RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN Irrigation Pump Connection Cable 3 Meter INTELLAGEN Serial Communication Cable 3 Meter INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Foot Pedal INTELLAGEN Remote Control Kit INTELLAGEN Remote Control Connection Cable 25 Meter INTELLAGEN Remote Control Connection Cable 10 Meter Cable, IntellaNav Ablation Catheter Rhythmia HDx Ablation Connection Box - for INTELLAGEN INTELLAGEN ECG Connection Cable 3 Meter INTELLAGEN Grounding Cable 3 Meter INTELLAGEN Irrigation Pump Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 30 Meter IntellaNav StablePoint Catheter Cable Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN INTELLAGEN RF Generator Kit INTELLAGEN Irrigation Pump Kit INTELLAGEN Tubing Set Cable IntellaTip MiFi OI to Maestro 4000 IntellaNav StablePoint Ablation Catheter INTELLAGEN Remote Control Connection Cable 15 Meter Cable, IntellaTip MiFi OI INTELLAGEN Irrigation Pump Connection Cable 1 Meter INTELLAGEN Foot Pedal Extension Cable 7 Meter INTELLAGEN Irrigation Pump Connection Cable 5 Meter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-08-29
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-08-05
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-03-14
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2015-11-25
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2008-08-07
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2014-11-10
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2019-04-23
PCU Pancreatic Stent, Covered, Metallic, Removable Gastroenterology, Urology Class 2 876.5015 2019-04-23
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2013-12-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-10-08
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-03-21
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2014-02-05
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2014-02-05
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2008-01-22
LPB Cardiac Ablation Percutaneous Catheter Unknown Class 3 N/A 2008-01-14
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 2017-08-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-12-02
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2010-10-28
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2010-10-28
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2015-10-05
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2016-03-24
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2017-06-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-12-10
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-22
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-01-14
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-06-20
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-09-09
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
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2023-07-15
OFK Percutaneous Atrial Catheter Kit Cardiovascular Class 2 870.1250 2024-08-07
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2014-10-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-04-22
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-01-26
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2017-01-26
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-01-26
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2017-01-26
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-09-05
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2012-03-09
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2012-03-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2008-01-03
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2013-12-16
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2013-08-12
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2014-10-29
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2016-05-12
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2016-05-12
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2016-12-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2023-01-20
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2023-01-20
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-03-19
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2008-01-03
MIR Shunt, Portosystemic, Endoprosthesis Unknown Class 3 N/A 2008-01-22
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2018-02-09
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-07-13
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2014-10-29
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2022-02-03
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2022-02-03
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
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-10-19
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2020-10-19
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2020-02-05
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2013-12-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-10
FFY Adaptor, Bulbs, Miscellaneous, For Endoscope Gastroenterology, Urology Class 1 876.1500 2005-08-10
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-03-14
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2014-10-21
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2022-04-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-12-22
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2024-06-03
NTE Temporary Carotid Catheter For Embolic Capture Cardiovascular Class 2 870.1250 2024-10-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-09-16
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 1992-07-22
MAV Syringe, Balloon Inflation Cardiovascular Class 2 870.1650 2014-09-26
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2021-05-04
NIO Stent, Iliac Unknown Class 3 N/A 2012-12-13
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2008-12-11
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2023-08-03
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2022-09-09
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
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2020-09-17
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2025-03-26
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-03-10
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-06-28
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
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2022-03-14
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-01-14
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2014-10-29
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2011-11-28
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2014-10-21
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2019-03-12
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2003-04-24
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-05-21
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2012-09-24
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2015-06-28
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-11-14
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2017-11-14
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
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-11-20
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2010-09-09
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2023-06-28
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-12-13
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-01-26
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2014-10-29
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2012-12-13
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2014-06-16
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2014-07-25
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2025-05-30
OTM Mesh, Surgical, For Stress Urinary Incontinence, Male General, Plastic Surgery Class 2 878.3300 2022-03-10
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2018-05-31
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2019-10-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2019-10-11
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-07-27
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2014-09-19
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2016-12-05
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2016-07-21
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-08-28
MQR Stent, Colonic, Metallic, Expandable General, Plastic Surgery Class 2 878.3610 2025-12-02
MUM Stent, Metallic, Expandable, Duodenal General, Plastic Surgery Class 2 878.3610 2025-12-02
PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling General, Plastic Surgery Class 2 878.3300 2008-12-11
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-01-03
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-06-24
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2004-09-13
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2016-05-20
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2016-05-20
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-10
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2020-05-27
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2020-05-27
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2020-05-27
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
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2025-12-31
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-01-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-10
FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-04-24
FDT Duodenoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2014-04-24
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2014-04-24
PWJ Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence Obstetrics/Gynecology Class 2 884.4910 2021-12-16
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2010-03-25
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2010-03-25
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2008-01-03
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2026-01-06
LJE Catheter, Nephrostomy Unknown Class U N/A 2026-01-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2017-05-18
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2016-12-22
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2024-01-31
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-04-04
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-23
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-08-24
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2006-09-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-08-21
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2008-01-03
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2016-12-22
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-12-23
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2016-12-23
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2008-01-03
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
OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed General, Plastic Surgery Class 2 878.3300 2013-03-17
GBM Catheter, Urethral Gastroenterology, Urology Class 2 876.5130 2008-01-03
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2022-03-14
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
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2020-03-30
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2024-01-09
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-11-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2008-01-03
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2021-09-27
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2022-08-30
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2020-10-21
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2020-10-21
NIO Stent, Iliac Unknown Class 3 N/A 2012-12-13
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2008-01-14
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-01-30
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2008-01-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-03-27
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2024-11-25
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2008-01-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-10
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2008-01-14
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
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2018-09-21
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2019-03-13
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2022-03-14
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-11-13
LQC Lithotriptor, Biliary Mechanical Gastroenterology, Urology Class 2 876.4500 2016-12-05
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2012-12-11
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2021-05-26
PTS Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt Gastroenterology, Urology Class 2 876.1500 2018-05-31
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-03-25
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-09-01
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2016-07-27
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2023-05-03
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2007-05-10
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 1983-09-09
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2022-04-26
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2022-04-26
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-09-05
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2022-06-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-10-15
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2011-04-25
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2018-05-24
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2015-03-31
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2013-06-04
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2012-09-20
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2023-05-03
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2023-05-03
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2010-09-15
OHD Gynecological Laparoscopic Kit Obstetrics/Gynecology Class 2 884.1720 2013-07-02
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2008-01-14
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2011-12-09
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2014-10-29
PNB Biliary Stent System For Benign Strictures Gastroenterology, Urology Class 2 876.5011 2026-02-18
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2026-02-18
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2016-12-20
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2020-03-30
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-05-08
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2015-08-05
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-01-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-02-16
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2008-01-03
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-12
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2010-12-07
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-02-06
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2017-02-06
ONU Drug-Eluting Peripheral Transluminal Angioplasty Catheter Unknown Class 3 N/A 2020-11-02
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2016-08-25
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2025-08-28
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2014-01-07
FCG Biopsy Needle Gastroenterology, Urology Class 2 876.1075 2014-01-07
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2008-01-14
QTD Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss Gastroenterology, Urology Class 2 876.5983 2023-05-03
QTD Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss Gastroenterology, Urology Class 2 876.5983 2023-10-16
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-01-14
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-12-11
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2012-08-22
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-05-01
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-01-24
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2017-03-29
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2013-11-13
FAE Prosthesis, Penile Gastroenterology, Urology Class 2 876.3630 2019-04-19
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2008-01-03
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-02-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2020-12-04
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2020-12-04
FQH Lavage, Jet General Hospital Class 2 880.5475 2020-12-04
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-12-12
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2023-08-22
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2003-04-18
FAD Stent, Ureteral Gastroenterology, Urology Class 2 876.4620 2025-05-08
FFA Tube, Drainage, Suprapubic Gastroenterology, Urology Class 2 876.5090 2025-05-08
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2021-05-03
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2022-03-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-05-17
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2024-12-17
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2022-05-12
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2024-08-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2008-01-22
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2002-01-15
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2006-08-22
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 1992-07-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-10-25
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-01-14
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2016-05-31
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2013-07-18
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2022-03-21
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-05
NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown Class 3 N/A 2018-09-24
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2021-06-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-05-11
NIN Stent, Renal Unknown Class 3 N/A 2008-12-23
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-01-11
IKD Cable, Electrode Physical Medicine Class 2 890.1175 1992-08-27
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-01-11
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2008-01-14
GBZ Catheter, Cholangiography General, Plastic Surgery Class 1 878.4200 2008-01-14
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2014-02-05
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2008-01-14
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2015-10-13
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2015-10-13
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2023-08-10
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-01-06
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2023-01-30
IWP Radiographic Protective Glove Radiology Class 1 892.6500 1992-07-22
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-09-30
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2014-02-18
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2012-09-20
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-07-19
OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter Unknown Class 3 N/A 2016-02-25
OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation Unknown Class 3 N/A 2016-02-25
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2008-01-14
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2008-01-14
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2008-01-10
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-08-06
PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse Obstetrics/Gynecology Class 2 884.4910 2018-03-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2009-12-07
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2015-10-06
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-10-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-01-11
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2022-03-29
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

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
K172288 Wilson-Cook Medical Inc./Cook Endoscopy Fusion OMNI Sphincterotome 2018-04-17
K792141 Pharmaseal Div., Baxter Healthcare Corp. CONTINUOUS FLUSH DEVICE 1979-12-05
K924661 Baxter Healthcare Corp SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER 1993-04-08
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Similar Registrations

Registration Number Establishment Name Location
3013526170 Jiangsu Vedkang Medical Science and Technology Co.,Ltd. Changzhou Jiangsu, CN
3002807310 Synergy Health Sterilisation UK Ltd Berkshire Reading, GB
1320894 CONMED CORPORATION Utica, NY, US
3014769442 Aomori Olympus Co., Ltd. Hirosaki Site Hirosaki-shi Aomori, JP
3002806337 Akita Sumitomo Bakelite Co., Ltd. Akita, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000121056. Last updated year: 2026. Please use registration number 1000121056 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.