Vortex Medical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Vortex Medical, Inc. makes
Vortex Medical, Inc. manufactures cannulas and cardiopulmonary bypass circuits designed for vascular access and extracorporeal circulation procedures. The ANGIOVAC CANNULA and VORTEX CANNULA are intended for use in catheter-based interventions, while the VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT supports temporary circulatory support during surgical procedures.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Angiovac Cannula Ref K133445
510(k) 510(k)Vortex Cannula Ref K091304
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Vortex Medical, Inc. have in the registry?
The registry currently lists 3 devices for Vortex Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vortex Medical, Inc.'s devices?
Among its 3 most recently registered devices, Vortex Medical, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Vortex Medical, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Vortex Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vortex Medical, Inc. in the registry?
The most recently registered devices listed for Vortex Medical, Inc. include ANGIOVAC CANNULA, VORTEX CANNULA and VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT.