# K121856: Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 11, 2012 after 15 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: 2 generations back to K012913 (2001). 2 ancestors in all.
14 later devices descend from it; 2 cite 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)
- K093965: Ultraverse 014 and 018 Balloon Dilatation Catheters, C.R. Bard, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- K152873: Crosstella RX Balloon Dilatation Catheter (2016), 1 descendant of its own

## Indications for use
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters Line Extension are recommended for use in Percutaneous Transluminal 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/K121856
Methodology: https://510kreport.com/methodology