# K142983: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating

- Pathway: 510(k) (Special)
- Applicant: Angioscore, Inc.
- Decided: Mar 4, 2015 after 139 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: 12 generations back to K971448 (1997). 44 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112182: Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2011) Summary page 5.
- K122685: Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2013) Summary page 5.
- K133998: Angiosculpt Pta Scoring Balloon with Hydrocross Caoting, Angioscore, Inc. (2014) Summary page 5.

## Most influential descendants
- 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
- K180958: Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable (2018), 4 descendants of its own
- K180454: Shockwave Medical Intravascular Lithotripsy (IVL) System (2018), 4 descendants of its own
- K191840: Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (2019), 3 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/K142983
Methodology: https://510kreport.com/methodology