# K182713: Scoreflex PTA Scoring Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Orbusneich Medical Trading, Inc.
- Decided: Jun 11, 2019 after 257 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.
No later device cites it as a predicate yet.
0 of 27 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.

## Indications for use
The Scoreflex PTA Scoring Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including 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 indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K182713
Methodology: https://510kreport.com/methodology