Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616693

FEI Number

3002618605

Entity Name

Boston Scientific Limited

City/State/Country

CLONMEL Tipperary, IE

Establishment Address

Cashel Road, CLONMEL Tipperary --, 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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P140004

All Registered Proprietary Names

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 FORMIO VITALIO ESSENTIO ACCOLADE PROPONENT ALTRUA 2 Screw Cap Wrench ALTRUA 60 INGENIO ALTRUA 40 ADVANTIO ALTRUA 20 INTUA VALITUDE VALITUDE X4 VISIONIST X4 VISIONIST INVIVE CONTAK RENEWAL TR Software Application Stylet INGEVITY MRI FORMIO MRI VITALIO MRI INGENIO MRI Suture Sleeve ESSENTIO MRI PROPONENT MRI ACCOLADE MRI 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 LATITUDE Clarity myLUX LUX-Dx Single Use Instrument (SUI) Kit Superion IDS, 10 mm Superion IDS, 14 mm Superion IDS, 16 mm Superion IDS, 8 mm Superion IDS, 12 mm Vertiflex Instrument Platform (VIP) Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2025-09-30
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2011-01-06
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2011-01-06
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2015-11-25
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2010-10-26
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2010-10-26
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2010-10-26
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2023-08-23
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2016-08-25
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2016-08-25
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2016-04-25
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2016-04-25
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
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2016-08-25
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Cardiovascular	Class 2	870.1025	2020-06-29
NQO	Prosthesis, Spinous Process Spacer/Plate	Unknown	Class 3	N/A	2019-11-14

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

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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
K253516	ABBOTT MEDICAL	Assert-IQ (DM5100)	2025-12-18
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30
K915007	Oscor Medical Corp.	PERMANENT PACING LEADS, MODIFICATION	1992-01-27
K020354	Baylis Medical Co., Inc.	BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL)	2002-05-03
K201610	ABBOTT MEDICAL	IonicRF Generator	2020-10-21

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 9616693. Last updated year: 2026. Please use registration number 9616693 when referencing this establishment in official correspondence.