Company · US
Cardio Flow Inc.,
FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2025 | K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) Cardio Flow Inc., | MCW |
| Nov 5, 2024 | K242947 | FreedomFlow Orbital Circumferential Atherectomy System Cardio Flow Inc., | MCW |
| Feb 15, 2024 | K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) Cardio Flow Inc., | MCW |
| Sep 27, 2023 | K231538 | FreedomFlow Orbital Circumferential Atherectomy System Cardio Flow Inc., | MCW |
| Mar 18, 2022 | K213834 | Cardio Flow Peripheral Guide Wire Cardio Flow Inc., | DQX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||