# K163420: UltraScore Focused Force PTA Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Jun 14, 2017 after 190 days
- Product code: PNO (Catheter, Percutaneous, Cutting/Scoring)
- 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: 7 generations back to K001134 (2000). 26 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103459: Vascutrak Pta Dilatation Catheter, C.R. Bard, Inc. (2010) Summary page 4.

## Most influential descendants
- K172571: ULTRASCORE Focused Force PTA Balloon (2017), 1 descendant of its own
- K261778: JADE SCORE PTA Scoring Balloon Dilatation Catheter (2026), 0 descendants of its own
- K260012: UltraScore™ Focused Force PTA Balloon (2026), 0 descendants of its own

## Indications for use
The UltraScore Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature.

Source page: https://510kreport.com/device/K163420
Methodology: https://510kreport.com/methodology