Medtronic CryoCath LP
Pointe-Claire Quebec, CA
Medtronic CryoCath LP appears in FDA device records in Pointe-Claire Quebec, CA. FDA records list 12 510(k) clearances between and , 254 PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Medtronic CryoCath LP carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Cryocath Technologies, Inc.510(k), recall
510(k) clearance history
FDA records hold 12 510(k) clearances for Medtronic CryoCath LP between 2003 and 2020. The busiest year on record is 2006, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202620 | FlexCath Advance Steerable Sheath and Dilator | DRA | Substantially Equivalent | |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | DRA | Substantially Equivalent | |
| K163268 | FlexCath Select Steerable Shealth and Dilator | DYB | Substantially Equivalent | |
| K142684 | FlexCath Select Steerable Sheath (10 French) | DYB | Substantially Equivalent | |
| K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | DRA | Substantially Equivalent | |
| K102176 | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 | DRA | Substantially Equivalent | |
| K081049 | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 | DRA | Substantially Equivalent | |
| K070357 | FLEXCATH STEERABLE SHEATH & DILATOR | DRA | Substantially Equivalent | |
| K062140 | SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 | OCL | Substantially Equivalent | |
| K053436 | SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE | OCL | Substantially Equivalent | |
| K040690 | SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE | OCL | Substantially Equivalent | |
| K030303 | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE | GEH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002648230 | 3002648230 | Medtronic CryoCath LP | 9000 Autoroute Transcanadienne, Pointe-Claire Quebec H9R 5Z8 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LPBCardiac Ablation Percutaneous Catheter
- OAECatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- DRACatheter, Steerable
- DYBIntroducer, Catheter
- QZIPercutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- OCLSurgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- GEHUnit, Cryosurgical, Accessories
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1452-06 | 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. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Medtronic CryoCath LP edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain