# K231538: FreedomFlow Orbital Circumferential Atherectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Cardio Flow Inc.,
- Decided: Sep 27, 2023 after 120 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: 8 generations back to K871011 (1987). 16 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K110389: Stealth 360 Orbital Pad System, Cardiovascular Systems, Inc. (2011) Summary page 5.

## Most influential descendants
- K233483: FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) (2024), 2 descendants of its own
- K242947: FreedomFlow™ Orbital Circumferential Atherectomy System (2024), 1 descendant of its own
- 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 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/K231538
Methodology: https://510kreport.com/methodology