# K172571: ULTRASCORE Focused Force PTA Balloon

- Pathway: 510(k) (Special)
- Applicant: C. R. Bard
- Decided: Sep 22, 2017 after 25 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: 8 generations back to K001134 (2000). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163420: UltraScore Focused Force PTA Balloon, Bard Peripheral Vascular, Inc. (2017) Summary page 4.

## Most influential descendants
- 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/K172571
Methodology: https://510kreport.com/methodology