# K012913: Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 28, 2001 after 29 days
- Product code: DQY (Catheter, Percutaneous)
- 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
No predicates in its family tree.
107 later devices descend from it; 2 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Bard® Opti-Plast™ PTA Catheter: named in the summary without a submission number
- (no number) Boston Scientific Symmetry™ Balloon Dilatation Catheter: named in the summary without a submission number

## Most influential descendants
- K072283: Dorado Pta Balloon Dilatation Catheter (2007), 96 descendants of its own
- K083657: Conquest Pta Balloon Dilatation Catheter (2008), 44 descendants of its own
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 descendants of its own
- K082579: Evercross .035 Otw Pta Dilatation Catheter (2008), 35 descendants of its own
- K112182: Angiosculpt Pta Scoring Balloon Catheter (2011), 29 descendants of its own

## Indications for use
The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal vessels. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K012913
Methodology: https://510kreport.com/methodology