# K252315: Santreva™-ATK Endovascular Revasculariztion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: AngioSafe, Inc.
- Decided: Sep 22, 2025 after 59 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: 6 generations back to K935425 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033535: Lumend Frontrunner Cto Catheter and Accessories, Lumend, Inc. (2004) Summary page 5.

## Indications for use
The Santreva™-ATK Endovascular Revascularization Catheter is intended to facilitate the intraluminal placement of guidewires beyond stenotic lesions, including Chronic Total Occlusions (CTOs), in the femoropopliteal (arterial) peripheral vasculature.

Source page: https://510kreport.com/device/K252315
Methodology: https://510kreport.com/methodology