# K171290: Vela RX PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Curatia Medical
- Decided: Jul 19, 2017 after 78 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: 4 generations back to K042537 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131199: Ultraverse RX Pta Balloon Dilatation Catheter, Bard Peripheral Vascular, Inc. (2013) Summary page 4.

## Indications for use
The Vela RX PTA Balloon Dilatation Catheter is intended for use in percutaneous transluminal angioplasty (PTA) of the femoral, popliteal, infra popliteal and renal arteries.

Source page: https://510kreport.com/device/K171290
Methodology: https://510kreport.com/methodology