# K081220: Modification to Angiosculpt Pta Scoring Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Angioscore, Inc.
- Decided: May 28, 2008 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: 5 generations back to K971448 (1997). 10 ancestors in all.
34 later devices descend from it; 3 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072225: Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2007) Summary page 4.
- K080151: Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039, Angioscore, Inc. (2008) Summary page 4.

## Most influential descendants
- K091966: Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040 (2009), 33 descendants of its own
- K100303: Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy (2010), 32 descendants of its own
- K110767: Angiosculpt Pta Scoring Balloon Catheter (2011), 30 descendants of its own
- K112182: Angiosculpt Pta Scoring Balloon Catheter (2011), 29 descendants of its own
- K101735: Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-Xxyy (2010), 29 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, and infra popliteal 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/K081220
Methodology: https://510kreport.com/methodology