# K251915: Amethyst HP PTA OTW 0.035 Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Natec Medical, Ltd.
- Decided: Dec 18, 2025 after 178 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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: 10 generations back to K933483 (1993). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241040: Amethyst HP PTA OTW 0.035 Catheter, Natec Medical, Ltd. (2024) Summary page 5.

## Indications for use
The Amethyst HP PTA OTW 0.035” Catheter is indicated for: - Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature including iliac, femoral, popliteal, tibial, peroneal, subclavian, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. - Post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K251915
Methodology: https://510kreport.com/methodology