# K221541: LimFlow ARC

- Pathway: 510(k) (Traditional)
- Applicant: LimFlow, Inc.
- Decided: Aug 31, 2022 after 96 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: 7 generations back to K001577 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150836: OUTBACK Elite Re-Entry Catheter, Cordis Corporation, A Johnson & Johnson Co. (2015) Summary page 4.

## Most influential descendants
- K251376: LimFlow ARC (2025), 0 descendants of its own

## Indications for use
The LimFlow ARC is intended to facilitate placement and positioning of guidewires 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/K221541
Methodology: https://510kreport.com/methodology