Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019751610

FEI Number

3019751610

Entity Name

Boston Scientific Corporation

City/State/Country

Mississauga Ontario, CA

Establishment Address

2775 Matheson Blvd E, Mississauga Ontario L4W 4P7, CA

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

K213582

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-03-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-05-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-14
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-03-14
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2022-03-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-03-21
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-08-14
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2022-03-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2022-03-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-01-08
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2023-08-03
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	1992-08-27
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
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2022-03-21
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2022-03-14
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-01-09
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-07-19

Official Correspondent

Adrienne Bishop

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
K881966	C.R. Bard, Inc.	ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER	1988-10-04
K192037	ABBOTT MEDICAL	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17
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
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04

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 3019751610. Last updated year: 2026. Please use registration number 3019751610 when referencing this establishment in official correspondence.