# K142261: Ultraverse 035 PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Sep 24, 2014 after 41 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: 6 generations back to K001134 (2000). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120722: Rival Pta Dilatation Catheter, Bard Peripheral Vascular, Inc. (2012) Summary page 4.

## Indications for use
The Ultraverse® 035 PTA Dilatation Catheter is intended to dilate stenoses in the peripheral arteries, to treat obstructive lesions of native or synthetic AV fistulae and/or re-expand endoluminal stent graft elements in the iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K142261
Methodology: https://510kreport.com/methodology