# K131199: Ultraverse RX Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: May 30, 2013 after 34 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: 3 generations back to K042537 (2004). 6 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121856: Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line Extension, C.R. Bard, Inc. (2012) Summary page 1.
- K100490: Litepac, Model 682, ClearStream Technologies, Ltd. (2010) Summary page 1.

## Most influential descendants
- 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
- K152873: Crosstella RX Balloon Dilatation Catheter (2016), 1 descendant of its own
- K252295: Ryurei (2026), 0 descendants of its own
- K211349: Selebrek PTCA Balloon Dilatation Catheter (2022), 0 descendants of its own

## Indications for use
Ultraverse® RX PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the renal, femoral, popliteal, infra-popliteal, tibial, and peroneal arteries. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K131199
Methodology: https://510kreport.com/methodology