# K122685: Angiosculpt Pta Scoring Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Angioscore, Inc.
- Decided: Jan 11, 2013 after 133 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: 10 generations back to K971448 (1997). 42 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101735: Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-Xxyy, Angioscore, Inc. (2010) Summary page 4.
- K112182: Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2011) Summary page 4.

## Most influential descendants
- K133998: Angiosculpt Pta Scoring Balloon with Hydrocross Caoting (2014), 24 descendants of its own
- K142983: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating (2015), 16 descendants of its own
- K161384: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (2016), 13 descendants of its own
- K163306: Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable (2016), 10 descendants of its own
- K150634: AngioSculpt PTA Scoring Baloon Catheters (2015), 6 descendants of its own

## Indications for use
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions 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. Not for use in the coronary or neuro-vasculature

Source page: https://510kreport.com/device/K122685
Methodology: https://510kreport.com/methodology