# K250723: FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)

- Pathway: 510(k) (Special)
- Applicant: Cardio Flow Inc.,
- Decided: Apr 25, 2025 after 46 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K871011 (1987). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242947: FreedomFlow™ Orbital Circumferential Atherectomy System, Cardio Flow Inc., (2024) Summary page 5.

## Indications for use
The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.

Source page: https://510kreport.com/device/K250723
Methodology: https://510kreport.com/methodology