# K251376: LimFlow ARC

- Pathway: 510(k) (Special)
- Applicant: LimFlow, Inc.
- Decided: May 31, 2025 after 29 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K001577 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221541: LimFlow ARC, LimFlow, Inc. (2022) Summary page 5.

## Indications for use
The LimFlow ARC is intended to facilitate placement and positioning of guide wires and catheters within the peripheral vasculature. The LimFlow ARC is not intended for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K251376
Methodology: https://510kreport.com/methodology