Cardio Flow Inc.,
United StatesFDA applicant, unverified
Cardio Flow Inc., is a medical device manufacturer, with 9 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 14 Nov 2026.
- Devices
- 9
Registry facts
- Registries
- FDA 510(k) 5
- FDA GUDID 4
- Device classes
- FDA Class II 9
- Identifiers
- DUNS 080505958
What Cardio Flow Inc., makes
Cardio Flow Inc. manufactures peripheral vascular guidewires and mechanical atherectomy system catheters designed for atherectomy procedures. Their guidewires are intended for manual navigation within peripheral arteries, while their orbital atherectomy systems use a rotating burr to remove calcified plaque in peripheral vessels. The FreedomFlow Orbital Circumferential Atherectomy System is available in multiple configurations, including 3-sphere and 4Fr/5Fr variants.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. The portfolio is authorised for use in the United States, where the manufacturer is based.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) Ref K250723
Regimes: 510(k) Registry: 510(k)Cardio Flow Peripheral Guide Wire Ref K213834
Regimes: 510(k) Registry: 510(k)FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) Ref K233483
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 080505958
- Phone
- 800-294-5517
Frequently asked questions
How many devices does Cardio Flow Inc., have in the registry?
The registry currently lists 9 devices for Cardio Flow Inc.,. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio Flow Inc.,'s devices?
Among its 9 most recently registered devices, Cardio Flow Inc., has devices listed in FDA 510(k) (5 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cardio Flow Inc.,'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Cardio Flow Inc.,'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio Flow Inc., in the registry?
The most recently registered devices listed for Cardio Flow Inc., include Cardio Flow Peripheral Guide Wire GW1001, FreedomFlow Orbital Circumferential Atherectomy System H6004, FreedomFlow Orbital Circumferential Atherectomy System H6001 and FreedomFlow Orbital Circumferential Atherectomy System H6002.