# K242947: FreedomFlow™ Orbital Circumferential Atherectomy System

- Pathway: 510(k) (Special)
- Applicant: Cardio Flow Inc.,
- Decided: Nov 5, 2024 after 41 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: 10 generations back to K871011 (1987). 18 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231538: FreedomFlow Orbital Circumferential Atherectomy System, Cardio Flow Inc., (2023) Summary page 5.
- K233483: FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration), Cardio Flow Inc., (2024) Summary page 5.

## Most influential descendants
- K250723: FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) (2025), 0 descendants of its own

## Indications for use
The FreedomFlow™ Orbital Circumferential Atherectomy System is indicated for use as a 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/K242947
Methodology: https://510kreport.com/methodology