Boston Scientific Corporation

FDA Device Registration & Listing · Dorado, PR, US · Registration 2648729

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
2648729
FEI Number
2648729
Entity Name
Boston Scientific Corporation
City/State/Country
Dorado, PR, US
Establishment Address
No. 12, RD. No. 698, Dorado, PR 00646, 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
N/A
PMA Number
P980037

All Registered Proprietary Names

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 ACUITY STEERABLE FLEXTEND Lead Stabilizer Kit Fixation Tool 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 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 Vercise DBS Controller Clinician Kit Vercise Physician's Spare Kit 8 Contact Extension Kit Vercise M8 Adapter Vercise Remote Control Vercise External Trial Stimulator Base Station Charger Clinician Programmer Power Supply for Tablet Computer Vercise Implantable Pulse Generator Kit Vercise Remote Control Kit Precision AC/DC Power Supply Bionic Navigator 24 Installer Tunneling Tool Cable, USB Serial Keyboard Patient Travel Case Remote Control Case Medical Adhesive Adhesive Kit Tablet Pen IR Interface ETS battery Vercise Charger Collar Charger Spacer SureTek Burr Hole Cover Kit Lead Kit Vercise Charging System Vercise DBS External Trial Stimulator 2 IR Interface Holder USB Splitter O.R. Cable and Extension Vercise Charger Collar Accessories Vercise PC Implantable Pulse Generator Kit AC/DC Power Supply Vercise Neural Navigator 2.1 Installer OR Cable 2x8, 61cm and Extension Precision Spectra IPG Port Plug Programming Wand SP3 Platform Update Installer Vercise DBS Remote Control 3 Vercise Gevia Implantable Pulse Generator Kit Vercise ETS Vercise DBS Remote Control 3 Kit Vercise DBS Directional Lead Kit Vercise Genus Implantable Pulse Generator Kits Pairing Magnet Vercise Neural Navigator 4 Installer Vercise DBS Remote Control 4 and Kit Vercise Neural Navigator 3.1 Installer Vercise ETS 3 Charger Belt and accessories Vercise Charging System with Belt Push Button OR Cable 2x8 Contact Lead Extension Kit Vercise Charger Vercise Neural Navigator 5 Vercise S8 Adapter Vercise ETS Adapter Vercise Physician's Spare Kit, 16 Contact Lead Vercise DBS Controller Vercise Cartesia HX Directional Lead Kit Lead Extension Kit, 16 Contact Vercise Cartesia X Directional Lead Kit Vercise DBS Controller Patient Kit Vercise Cartesia Directional Lead Kit J Shaped Lead Stylet Straight Lead Stylet FINELINE II Sterox FINELINE II EZ Sterox Suture Sleeves 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 AngioJet Ultra 5000A Console AngioJet Spiroflex Thrombecotmy Set AngioJet Spiroflex VG Thrombectomy Set AutoElite Thrombectomy System Console

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2014-10-29
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
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2014-10-29
OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Unknown Class 3 N/A 2010-10-28
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2010-10-28
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
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
NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms Unknown Class 3 N/A 2020-07-27
QEW Peripheral Mechanical Thrombectomy With Aspiration Cardiovascular Class 2 870.5150 2014-10-29
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
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
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 2014-10-29
QEZ Aspiration Thrombectomy Catheter Cardiovascular Class 2 870.5150 2014-10-29
PJS Stimulator, Electrical, Implanted, For Essential Tremor Unknown Class 3 N/A 2017-12-10
MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor Unknown Class 3 N/A 2017-12-10
NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms Unknown Class 3 N/A 2017-12-10
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
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
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
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
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2014-10-29

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
K232458 ABBOTT MEDICAL JETi™Hydrodynamic Thrombectomy System 2023-12-19
K243549 ABBOTT MEDICAL JETi Hydrodynamic Thrombectomy System 2025-04-04
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
K915007 Oscor Medical Corp. PERMANENT PACING LEADS, MODIFICATION 1992-01-27

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
3040099838 FLOWPHYSIX, INC. West Lake Hills, TX, US
3002807314 Synergy Health Ireland Ltd Tullamore Offaly, IE
3031788372 CONTROL MEDICAL TECHNOLOGY South Salt Lake, UT, US
2011171 Sterigenics US LLC Los Angeles, CA, US
9681260 Boston Scientific Limited GALWAY, IE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2648729. Last updated year: 2026. Please use registration number 2648729 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.