# K241040: Amethyst HP PTA OTW 0.035 Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Natec Medical, Ltd.
- Decided: Dec 18, 2024 after 246 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: 9 generations back to K933483 (1993). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212588: Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter, C.R. Bard, Inc. (2022) Summary page 5.
- K120660: Conquest 40 Pta Dilatation Catheter, Bard Peripheral Vascular, Inc. (2012) Summary page 5.

## Most influential descendants
- K251915: Amethyst HP PTA OTW 0.035 Catheter (2025), 0 descendants of its own

## 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/K241040
Methodology: https://510kreport.com/methodology