Data / Medical devices / United States / Cardio Flow, Inc.
Cardio Flow, Inc.: FDA-registered device maker in Blaine, MN, United States, 2 510(k) clearances
Cardio Flow, Inc. is registered with the FDA (registration 3015124694) in Blaine, MN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015124694
- Address
- 3530 88th Ave NE, Blaine, MN, United States, 55014
- Owner or operator
- Cardio Flow, Inc. (10084699)
- Roles
- Specification developer
- First device listed
- March 23, 2022
- Registered through
- 2026
- Brand names listed
- FreedomFlow, FreedomFlow Orbital Circumferential Atherectomy System, FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Peripheral, Atherectomy | MCW | 2 | Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 27, 2023 | K231538 | FreedomFlow Orbital Circumferential Atherectomy System | MCW | Substantially Equivalent | Cardio Flow Inc., | accessdata.fda.gov |
| March 18, 2022 | K213834 | Cardio Flow Peripheral Guide Wire | DQX | Substantially Equivalent | Cardio Flow Inc., | accessdata.fda.gov |
Compare with other makers
Updated September 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.