# K093965: Ultraverse 014 and 018 Balloon Dilatation Catheters

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 17, 2010 after 84 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 K012913 (2001). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012913: Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter, C.R. Bard, Inc. (2001) Summary page 1.

## Most influential descendants
- K121856: Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension (2012), 14 descendants of its own
- K131199: Ultraverse RX Pta Balloon Dilatation Catheter (2013), 11 descendants of its own
- K150865: Metacross RX PTA Balloon Dilitation Catheter (2015), 4 descendants of its own
- K180921: Sapphire II PRO Balloon Dilatation Catheter (2018), 3 descendants of its own
- K192318: Ultraverse 014 and 018 PTA Balloon Dilatation Catheters (2019), 1 descendant of its own

## Indications for use
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Translumninal Angioplasty of the renal. tibial, popiteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.

Source page: https://510kreport.com/device/K093965
Methodology: https://510kreport.com/methodology