Cardio Vascular Concepts, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Cardio Vascular Concepts, Inc. makes
Cardio Vascular Concepts, Inc. manufactures vascular access devices, including the RAPID-TRAK™ INTRODUCER SHEATH for catheter insertion and the MOLLRING CUTTER for vascular closure.
These products fall under FDA Class II regulation and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Rapid-Trak(Tm) Introducer Sheath Ref K950155
Regimes: 510(k) Registry: 510(k)Mollring Cutter Ref K950813
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio Vascular Concepts, Inc. have in the registry?
The registry currently lists 2 devices for Cardio Vascular Concepts, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio Vascular Concepts, Inc.'s devices?
Among its 2 most recently registered devices, Cardio Vascular Concepts, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Cardio Vascular Concepts, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cardio Vascular Concepts, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio Vascular Concepts, Inc. in the registry?
The most recently registered devices listed for Cardio Vascular Concepts, Inc. include RAPID-TRAK(TM) INTRODUCER SHEATH and MOLLRING CUTTER.