# K964881: Ultraverse Pta Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vas-Cath, Inc.
- Decided: May 28, 1997 after 174 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: 1 generation back to K925485 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925485: Vas-Cath Inc. Opti-Plast Angioplasty Catheter, Vas-Cath, Inc. (1994) Summary page 1.

## Indications for use
The Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in angioplasty of the peripheral vascular system. The catheter is recommended for use in the following vessels: renal, tibial, popliteal, femoral, and peroneal. The catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K964881
Methodology: https://510kreport.com/methodology