# Cardio Flow Inc.,

- Location (FDA's records): Blaine, MN
- FDA decisions: 5 (2022–2025): 5 510(k) clearances
- Product codes: MCW (4), DQX (1)
- 510(k) review time since 2016: median 99 days, against 46 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Asahi Intecc Co., Ltd.: 2 (https://510kreport.com/company/asahi-intecc)
- Cardiovascular Systems, Inc.: 1 (https://510kreport.com/company/cardiovascular-systems)

## Its most-cited devices
- K231538: FreedomFlow Orbital Circumferential Atherectomy System (2023), cited by 2
- K233483: FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) (2024), cited by 1
- K242947: FreedomFlow™ Orbital Circumferential Atherectomy System (2024), cited by 1

## Recent decisions
- K250723: FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) (Apr 25, 2025)
- K242947: FreedomFlow™ Orbital Circumferential Atherectomy System (Nov 5, 2024)
- K233483: FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) (Feb 15, 2024)
- K231538: FreedomFlow Orbital Circumferential Atherectomy System (Sep 27, 2023)
- K213834: Cardio Flow Peripheral Guide Wire (Mar 18, 2022)

Source page: https://510kreport.com/company/cardio-flow