# K260304: WAVE PTA Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: WAVE Medical AG
- Decided: May 20, 2026 after 110 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: 8 generations back to K001134 (2000). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102705: Armada 14 Pta Catheter, Abbott Vascular, Inc. (2010) Summary page 5.

## Indications for use
The WAVE PTA Balloon Catheter is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K260304
Methodology: https://510kreport.com/methodology