# K050629: Angiosculpt Scoring Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Angioscore, Inc.
- Decided: Sep 2, 2005 after 175 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: 2 generations back to K971448 (1997). 7 ancestors in all.
38 later devices descend from it; 4 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013581: Cordis Aviator Peripheral Dilatation Catheter, Cordis, A Johnson & Johnson Co. (2001) Summary page 4.
- K971010: Peripheral Transluminal Angioplasty Catheters, Cordis Corp. (1997) Summary page 4.

## Most influential descendants
- K072225: Angiosculpt Pta Scoring Balloon Catheter (2007), 37 descendants of its own
- K080151: Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 (2008), 36 descendants of its own
- K082059: Angiosculpt Pta Scoring Balloon Catheter (2008), 34 descendants of its own
- K081220: Modification to Angiosculpt Pta Scoring Balloon Catheter (2008), 34 descendants of its own
- K091966: Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040 (2009), 33 descendants of its own

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

Source page: https://510kreport.com/device/K050629
Methodology: https://510kreport.com/methodology