Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002648230

FEI Number

3002648230

Entity Name

Medtronic CryoCath LP

City/State/Country

Pointe-Claire Quebec, CA

Establishment Address

9000 Autoroute Transcanadienne, Pointe-Claire Quebec H9R 5Z8, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P100010

All Registered Proprietary Names

FlexCath Advance FlexCath Select PulseSelect Pulsed Field Ablation (PFA) Freezor MAX Freezor cardiac cryoablation catheter Freezor MAX Surgical cryoablation catheter Freezor Xtra Surgical cardiac cryoablation catheter Cryoconsole Freezor Xtra cardiac cryoablation catheter ECG Cable Coaxial Cable Nitron Remote Nitron CryoConsole Freezor Freezor Xtra Freezor MAX cardiac cryoablation catheter Arctic Front Advance cardiac cryoablation catheter Arctic Front Advance ProTM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2019-02-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-05-08
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2023-12-15
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2015-09-25
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2013-03-28
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2026-05-26
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2013-03-28

Official Correspondent

No official correspondent registered.

US Agent Details

Rashmi Bhushan Business: MEDTRONIC, INC. Email: rashmi.g.bhushan@medtronic.com Phone: (763) 6070535

Related Public Records

Same Entity

Medtronic, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K884337	Catheter Research C/O Burditt, Bowles & Radzius	MICRO-GUIDE SYSTEM	1989-01-05
K162925	Acutus Medical, Inc.	AcQGuide Steerable Sheath	2017-04-06
K221397	ABBOTT MEDICAL	MitraClip G4 Steerable Guide Catheter	2022-09-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

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2182208	MEDTRONIC, INC.	Mounds View, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002648230. Last updated year: 2026. Please use registration number 3002648230 when referencing this establishment in official correspondence.