BOSTON SCIENTIFIC CORPORATION

FDA Device Registration & Listing · Cartago, CR · Registration 3025341484

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
3025341484
FEI Number
3025341484
Entity Name
BOSTON SCIENTIFIC CORPORATION
City/State/Country
Cartago, CR
Establishment Address
Zona Franca La Lima, Cartago 30106, CR
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
K233647
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
OFK Percutaneous Atrial Catheter Kit Cardiovascular Class 2 870.1250 2024-08-07
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2022-03-14
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2022-03-14
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2025-08-28
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2022-03-21
DXF Catheter, Septostomy Cardiovascular Class 2 870.5175 2025-01-24
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2022-03-14
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2021-09-01
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2024-01-09

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 3025341484. Last updated year: 2026. Please use registration number 3025341484 when referencing this establishment in official correspondence.
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