# K192318: Ultraverse 014 and 018 PTA Balloon Dilatation Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Oct 3, 2019 after 38 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 K012913 (2001). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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 4.

## Most influential descendants
- K223177: Highlander™ 014 PTA Balloon Dilatation Catheter (2023), 0 descendants of its own

## Indications for use
Ultraverse® 014 and Ultraverse® 018 PTA Balloon Dilatation Catheters are recommended for use in percutaneous trasluminal angioplasty (PTA) of the renal, popliteal, tibial, femoral, and peroneal arteries. These catheters are not for use in coronary arteries.

Source page: https://510kreport.com/device/K192318
Methodology: https://510kreport.com/methodology