Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027305778

FEI Number

3027305778

Entity Name

Cryterion Medical Inc.

City/State/Country

Saint Laurent Quebec, CA

Establishment Address

5920 Boulevard Henri-Bourassa Ouest, Saint Laurent Quebec H4R 1V9, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

P220032

All Registered Proprietary Names

SMARTFREEZE Cryo-Cable SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Console SMARTFREEZE Inter-Connection Box SMARTFREEZE Cryo-Console Foot Switch POLARx Cryoablation Balloon Catheter SMARTFREEZE Remote Control POLARx FIT Cryoablation Balloon Catheter SMARTFREEZE Diaphragm Movement Sensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-08-10

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 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
3017128979	CRC EP, INC.	Tustin, CA, US
1650907	Isomedix Operations Inc.	GRAND PRAIRIE, TX, US
3012179728	St. Jude Medical	Roseville, MN, US
3008093809	FOXCONN BAJA CALIFORNIA S.A DE C.V.	tijuana Baja California, MX
1319639	Sterigenics U.S., LLC	Queensbury, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027305778. Last updated year: 2026. Please use registration number 3027305778 when referencing this establishment in official correspondence.