# K150634: AngioSculpt PTA Scoring Baloon Catheters

- Pathway: 510(k) (Special)
- Applicant: Spectranetrics
- Decided: Apr 8, 2015 after 28 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.
6 later devices descend from it; 3 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133998: Angiosculpt Pta Scoring Balloon with Hydrocross Caoting, Angioscore, Inc. (2014) Summary page 4.
- K091966: Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040, Angioscore, Inc. (2009) Summary page 4.

## Most influential descendants
- K193495: XO Score Percutaneous Transluminal Angioplasty Scoring Catheter (2020), 2 descendants of its own
- K232013: Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) (2024), 1 descendant of its own
- K221986: XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter (2022), 1 descendant of its own
- K243944: Aperta NSE PTA Balloon Dilatation Catheter (2025), 0 descendants of its own
- K241478: Tri-Wedge PTA Scoring Balloon Dilatation Catheter (2024), 0 descendants of its own

## Indications for use
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/K150634
Methodology: https://510kreport.com/methodology