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Medtronic CryoCath LP: FDA-registered device maker in Pointe-Claire Quebec, Canada, 4 510(k) clearances and 3 PMA approvals

Name: Medtronic CryoCath LP FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medtronic CryoCath LP is registered with the FDA (registration 3002648230) in Pointe-Claire Quebec, Canada. It lists 5 device types. The FDA files 4 510(k) clearances and 3 PMA approvals under its listings, the newest dated December 13, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002648230
Address: 9000 Autoroute Transcanadienne, Pointe-Claire Quebec, Canada, H9R 5Z8
Owner or operator: Medtronic, Inc. (2112641)
Roles: Manufacturer
First device listed: March 28, 2013
Registered through: 2026
Brand names listed: Arctic Front Advance ProTM, Arctic Front Advance cardiac cryoablation catheter, Coaxial Cable, Cryoconsole, ECG Cable, FlexCath Advance, FlexCath Advance Steerable Sheath and Dilator, FlexCath Select and more

Devices it lists

Device	Product code	Class	Role	Source
Cardiac Ablation Percutaneous Catheter	LPB	3	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3	Manufacturer	accessdata.fda.gov
Catheter, Steerable	DRA	2	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	QZI	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 13, 2020	K202620	FlexCath Advance Steerable Sheath and Dilator	DRA	Substantially Equivalent	Medtronic Cryocath, LP	accessdata.fda.gov
November 26, 2018	K183174	FlexCath Advance Steerable Sheath and Dilator	DRA	Substantially Equivalent	Medtronic Cryocath, LP	accessdata.fda.gov
February 2, 2017	K163268	FlexCath Select Steerable Shealth and Dilator	DYB	Substantially Equivalent	Medtronic Cryocath, LP	accessdata.fda.gov
December 27, 2012	K123591	FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)	DRA	Substantially Equivalent	Medtronic Cryocath, LP	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 13, 2023	P230017	PulseSelect Pulsed Field Ablation (PFA) system	QZI	11	June 30, 2026	accessdata.fda.gov
December 17, 2010	P100010	ARCTIC FRONT CRYOCATHETER SYSTEM	OAE	151	September 25, 2026	accessdata.fda.gov
April 17, 2003	P020045	7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM	LPB	102	April 23, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 4, 2006	36087	Not yet classified	Terminated	7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.	Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.	accessdata.fda.gov

Compare with other makers

Updated June 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.