Boston Scientific Limited

FDA Device Registration & Listing · GALWAY, IE · Registration 9681260

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
9681260
FEI Number
3002806565
Entity Name
Boston Scientific Limited
City/State/Country
GALWAY, IE
Establishment Address
BALLYBRIT BUSINESS PARK, GALWAY --, IE
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
K193279
PMA Number
N/A

All Registered Proprietary Names

Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device Flextome Cutting Balloon Microsurgical Dilatation Device AngioJet Ultra 5000A Console AngioJet Spiroflex Thrombecotmy Set AngioJet Spiroflex VG Thrombectomy Set AutoElite Thrombectomy System Console WALLSTENT RP Endoprosthesis Self-Expanding Stent 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 Trapezoid RX Wireguided Retrieval Basket WALLSTENT RP Endoprosthesis Self-Expanding Stent WALLSTENT Endoprosthesis Self-Expanding Stent WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System 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 REBEL Platinum Chromium Coronary Stent System Carotid WALLSTENT Monorail Endoprosthesis 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 Express SD Renal/Biliary Premounted Stent System WALLSTENT Endoprosthesis Self-Expanding Stent WALLSTENT RP Endoprosthesis Self-Expanding Stent VENOUS WALLSTENT Self-Expanding Stent 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 AGENT Paclitaxel-Coated Balloon Catheter 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 ELUVIA Drug-Eluting Vascular Stent System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2010-09-15
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2014-10-21
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2015-06-28
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2018-02-09
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2012-09-20
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2017-05-18
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
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-03-27
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2014-10-29
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
FDX Endoscopic Cytology Brush Gastroenterology, Urology Class 2 876.1500 2008-01-14
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2008-01-14
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-01-11
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-12-12
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-08-15
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2011-08-15
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
EZN Dilator, Catheter, Ureteral Gastroenterology, Urology Class 2 876.5470 2008-01-03
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-05
PIF Gastrointestinal Tubes With Enteral Specific Connectors Gastroenterology, Urology Class 2 876.5980 2016-07-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-05-06
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2012-08-22
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
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2014-10-29
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2009-09-08
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
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2021-05-03
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2014-04-22
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-10-13
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
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-12-13
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-10
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-09-27
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-09-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-02-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-06-29
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2014-06-16
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
FBK Endoscopic Injection Needle, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2018-02-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2008-01-14
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2023-08-29
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-08-29
IKD Cable, Electrode Physical Medicine Class 2 890.1175 1992-08-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-12-22
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2012-12-11
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-01-06
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
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-03-10
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 2022-06-30
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 1983-09-09
QTD Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss Gastroenterology, Urology Class 2 876.5983 2023-10-16
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2018-05-31
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
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2024-05-02
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-03-25
FDT Duodenoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2019-12-17
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2019-12-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2008-11-05
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
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2014-10-21
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-05-08
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2021-05-26
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
PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse Obstetrics/Gynecology Class 2 884.4910 2018-03-09
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2016-12-20
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2014-09-05
ODD Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula Gastroenterology, Urology Class 2 876.1500 2008-01-14
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-10-28
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2015-06-08
PNO Catheter, Percutaneous, Cutting/Scoring Cardiovascular Class 2 870.1250 2007-11-29
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-10
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2015-10-05
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2008-01-03
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2003-04-18
LQC Lithotriptor, Biliary Mechanical Gastroenterology, Urology Class 2 876.4500 2016-12-05
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2016-07-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
NJE Intracranial Neurovascular Stent Unknown Class f N/A 2008-01-10
MIR Shunt, Portosystemic, Endoprosthesis Unknown Class 3 N/A 2008-01-22
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2012-01-06
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-01-14
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-03-19
PNO Catheter, Percutaneous, Cutting/Scoring Cardiovascular Class 2 870.1250 2015-07-21
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 2017-03-29
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2016-12-22
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-11-20
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
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
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2011-12-09
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2023-06-28
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2019-03-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-10-15
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-05-21
NGV System, Appendage Closure, Left Atrial Unknown Class 3 N/A 2015-03-17
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2024-12-17
NIQ Coronary Drug-Eluting Stent Unknown Class 3 N/A 2011-11-28
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2008-08-07
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2017-09-16
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2025-05-30
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2013-07-18
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-01-14
GBO Catheter, Nephrostomy, General & Plastic Surgery General, Plastic Surgery Class 1 878.4200 2005-08-01
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2014-02-05
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-11-13
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2013-12-23
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2008-01-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2018-10-08
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2013-08-12
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 2023-09-30
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2025-08-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-01-11
MAF Stent, Coronary Unknown Class 3 N/A 2014-07-22
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
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-07-27
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2015-12-14
FGX Snare, Non-Electrical Gastroenterology, Urology Class 1 876.4730 2018-05-24
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2008-01-14
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 2024-02-05
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2011-10-25
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-08-29
OCW Endoscopic Tissue Approximation Device Gastroenterology, Urology Class 2 876.1500 2023-08-22
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2017-11-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2010-12-07
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2015-03-31
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-10
NIM Stent, Carotid Unknown Class 3 N/A 2008-12-24
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2021-09-27
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
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
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-08-21
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2008-01-22
NIN Stent, Renal Unknown Class 3 N/A 2008-12-23
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
KTI Bronchoscope Accessory Ear, Nose, Throat Class 2 874.4680 2017-06-30
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2010-09-09
FEQ Pump, Air, Non-Manual, For Endoscope Gastroenterology, Urology Class 2 876.1500 2016-12-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-10
QKJ Stent, Central Venous Unknown Class 3 N/A 2008-01-22
QAN Stent, Iliac Vein Unknown Class 3 N/A 2008-01-22
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2016-05-31
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2015-11-25
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2021-06-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-22
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2008-01-22
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2013-01-23
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2022-08-30
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2020-08-05
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2024-11-25
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-07-13
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-08-14
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2020-09-17
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2008-01-03
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 2025-08-28
QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown Class 3 N/A 2024-01-31
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2008-01-03
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2023-05-08
DRA Catheter, Steerable Cardiovascular Class 2 870.1280 2023-05-08
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2025-05-01
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2006-08-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2008-01-10
GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection Gastroenterology, Urology Class 2 876.5010 2022-05-12
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2023-01-30
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2022-04-12
IWP Radiographic Protective Glove Radiology Class 1 892.6500 1992-07-22
BTG Brush, Biopsy, Bronchoscope (Non-Rigid) Ear, Nose, Throat Class 2 874.4680 2008-01-14
ODC Endoscope Channel Accessory Gastroenterology, Urology Class 2 876.1500 2025-12-31
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
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2012-12-11
PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling General, Plastic Surgery Class 2 878.3300 2008-12-11
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2024-06-13
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2008-01-03
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2014-10-29
MJN Catheter, Intravascular Occluding, Temporary Cardiovascular Class 2 870.4450 2013-11-13
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2016-12-15
LJE Catheter, Nephrostomy Unknown Class U N/A 2012-09-28
OOB Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter Unknown Class 3 N/A 2024-03-12
LQR Dislodger, Stone, Biliary Gastroenterology, Urology Class 2 876.5010 2020-02-05
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
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2014-09-19
LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular Class 2 870.1250 2012-12-13
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2023-06-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-08-24
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2016-12-05
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2012-12-13
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2023-07-15
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2019-01-25
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2019-01-25
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2019-01-25
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2013-12-16
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
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
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2008-01-11
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous Cardiovascular Class 2 870.5100 2012-12-10
EZB Stylet For Catheter, Gastro-Urology Gastroenterology, Urology Class 1 876.5130 2002-01-15
NIU Stent, Superficial Femoral Artery, Drug-Eluting Unknown Class 3 N/A 2018-09-24
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2019-10-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2019-10-11
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
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2014-05-29
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
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2016-03-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2025-05-01
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 1999-03-08
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-01-26
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
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2020-03-30

Official Correspondent

No official correspondent registered.

US Agent Details

Aaron Dunbar Business: BOSTON SCIENTIFIC CORPORATION Email: aaron.dunbar@bsci.com Phone: (651) 3961414

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
K902734 Olympus Corp. PR CANNULAS 1990-08-22
K051067 LeMaitre Vascular, Inc. PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT) 2005-05-27
K093847 Thermopeutix, Inc. DUFLO CATHETER (HEPARIN COATED) 2010-08-25
K171251 Creagh Medical 014 Hydrophilic Coated PTA Balloon Dilatation Catheter 2017-09-08
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681260. Last updated year: 2026. Please use registration number 9681260 when referencing this establishment in official correspondence.
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