Cardio-Dynamics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Cardio-Dynamics, Inc. makes
Cardio-Dynamics, Inc. manufactures balloon dilatation catheters for coronary and peripheral vascular applications, including the FOCUS PC, CVD Small Vessel, and CVD Periflow balloon catheters, as well as peripheral infusion catheters like the Bullett. These devices are designed for angioplasty procedures and targeted drug or fluid delivery in small and peripheral blood vessels.
The company’s products are classified under FDA Class II devices and are authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.
Catalogue
Focus Pc Balloon Dilatation Catheter Ref K954313
Regimes: 510(k) Registry: 510(k)Bullett Peripheral Infusion Catheter Ref K931027
Regimes: 510(k) Registry: 510(k)Cvd Small Vessel Balloon Dilation Catheter Ref K942150
Regimes: 510(k) Registry: 510(k)Cvd Periflow(Tm) Balloon Dilatation Catheter Ref K945943
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio-Dynamics, Inc. have in the registry?
The registry currently lists 4 devices for Cardio-Dynamics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio-Dynamics, Inc.'s devices?
Among its 4 most recently registered devices, Cardio-Dynamics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Cardio-Dynamics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Cardio-Dynamics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio-Dynamics, Inc. in the registry?
The most recently registered devices listed for Cardio-Dynamics, Inc. include FOCUS PC BALLOON DILATATION CATHETER, BULLETT PERIPHERAL INFUSION CATHETER, CVD SMALL VESSEL BALLOON DILATION CATHETER and CVD PERIFLOW(TM) BALLOON DILATATION CATHETER.