# K223177: Highlander™ 014 PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 20, 2023 after 101 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: 4 generations back to K012913 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192318: Ultraverse 014 and 018 PTA Balloon Dilatation Catheters, Bard Peripheral Vascular, Inc. (2019) Summary page 4.

## Indications for use
The Highlander™ 014 PTA Balloon Dilatation Catheter is indicated for use in percutaneous transluminal angioplasty (PTA) of the peripheral vasculature, including femoral, popliteal, infra-popliteal and renal arteries. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in coronary arteries.

Source page: https://510kreport.com/device/K223177
Methodology: https://510kreport.com/methodology