Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225687

FEI Number

3001451463

Entity Name

Boston Scientific Corp., Marina Bay Cust. Fulfillment Center

City/State/Country

QUINCY, MA, US

Establishment Address

500 Commander Shea Boulevard, QUINCY, MA 02171, 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

Expiration Date (Year)

2026

510(k) Number

K112198

PMA Number

N/A

All Registered Proprietary Names

ELUVIA Drug-Eluting Vascular Stent System 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 AGENT Paclitaxel-Coated Balloon Catheter Ranger Paclitaxel-Coated PTA Balloon Catheter Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System 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 WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System 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 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 Epic Vascular Self-Expanding Stent System Innova Vascular Self-Expanding Stent System Gateway PTA Dilatation Catheter Emerge Push PTCA Dilatation Catheter Emerge PTCA Dilatation Catheter NC Emerge PTCA Dilatation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2013-11-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-11-01
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2008-11-05
NIU	Stent, Superficial Femoral Artery, Drug-Eluting	Unknown	Class 3	N/A	2018-09-24
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2012-09-28
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-01-23
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
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2026-03-17
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2023-06-28
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2013-07-18
OTM	Mesh, Surgical, For Stress Urinary Incontinence, Male	General, Plastic Surgery	Class 2	878.3300	2022-03-10
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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-05-01
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2020-05-01
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2020-09-17
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
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
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2026-01-06
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2026-01-06
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
OOB	Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	Unknown	Class 3	N/A	2024-03-12
PIF	Gastrointestinal Tubes With Enteral Specific Connectors	Gastroenterology, Urology	Class 2	876.5980	2016-07-21
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
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
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-09-20
FFK	Lithotriptor, Electro-Hydraulic	Gastroenterology, Urology	Class 2	876.4480	2008-08-07
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2011-12-09
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2022-03-21
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-03-14
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
FDI	Snare, Flexible	Gastroenterology, Urology	Class 2	876.4300	2015-03-31
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2019-08-29
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2023-12-15
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-04-12
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2024-06-13
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2020-11-02
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2014-10-29
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
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
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2012-09-20
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2011-11-28
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2020-06-05
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2021-03-16
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-03-14
NIQ	Coronary Drug-Eluting Stent	Unknown	Class 3	N/A	2015-10-05
NGV	System, Appendage Closure, Left Atrial	Unknown	Class 3	N/A	2015-03-17
MCX	Catheter, Coronary, Atherectomy	Unknown	Class 3	N/A	2008-01-22
GBO	Catheter, Nephrostomy, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2005-08-01
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2019-10-10
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2020-03-30
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
NIO	Stent, Iliac	Unknown	Class 3	N/A	2012-12-13
NIP	Stent, Superficial Femoral Artery	Unknown	Class 3	N/A	2015-08-05
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2014-09-05
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2022-03-14
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
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2010-12-17
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	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

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

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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
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-06	Boston Scientific Corporation	3	Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS
Z-0041-06	Boston Scientific Corporation	2	Enteryx Injector Single Pack Order Number: M00572650-US and M00572630 -OUS
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225687. Last updated year: 2026. Please use registration number 1225687 when referencing this establishment in official correspondence.