Medtronic Cryocath, LP
Country not established FDA
- Devices
- 12
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Medtronic Cryocath, LP makes
Medtronic Cryocath manufactures steerable sheaths and dilators for cardiac procedures, including sizes such as 10 French and 12 French variants, designed for precise catheter navigation. Their product line also includes cryoablation catheters and console systems, such as the Freezor Cardiac Cryoablation Catheter and the Freezor MAX Catheter, which utilize cryotherapy for tissue treatment. These devices are intended for use in electrophysiology interventions, particularly within the heart.
The company’s devices are regulated under FDA pathways, with Class II and Class III classifications, and are authorised through 510(k) clearances and Premarket Approval Applications (PMA). Their products are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Catalogue
Search and filter all 12 devicesCompany details
- DUNS number
- 243829566
- [email protected]
- Phone
- +1(800)633-8766
FDA establishments
- Medtronic CryoCath LP Pointe-Claire Quebec · CA FEI 3002648230
Frequently asked questions
How many devices does Medtronic Cryocath, LP have in the registry?
The registry currently lists 12 devices for Medtronic Cryocath, LP. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Cryocath, LP's devices?
Among its 12 most recently registered devices, Medtronic Cryocath, LP has devices listed in FDA 510(k) (6 devices), FDA PMA (2 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medtronic Cryocath, LP's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Medtronic Cryocath, LP's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic Cryocath, LP in the registry?
The most recently registered devices listed for Medtronic Cryocath, LP include NA 106A3, FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10, FlexCath Advance Steerable Sheath and Dilator and FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH).
Which FDA establishments are linked to Medtronic Cryocath, LP?
1 FDA establishment is linked to Medtronic Cryocath, LP in the registry; they are listed on the company page.