# K080151: Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039

- Pathway: 510(k) (Traditional)
- Applicant: Angioscore, Inc.
- Decided: Apr 25, 2008 after 94 days
- Product code: PNO (Catheter, Percutaneous, Cutting/Scoring)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K971448 (1997). 9 ancestors in all.
36 later devices descend from it; 5 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.
- K050629: Angiosculpt Scoring Balloon Catheter, Angioscore, Inc. (2005) Summary page 4.
- K072225: Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2007) Summary page 4.

## Most influential descendants
- 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
- 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

## Recalls of this device
- Nov 16, 2010 · Not classified · Z-0839-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.
- Nov 16, 2010 · Not classified · Z-0840-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.
- Nov 16, 2010 · Not classified · Z-0842-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.
- Nov 16, 2010 · Not classified · Z-0838-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.
- Nov 16, 2010 · Not classified · Z-0841-2011: Reports of distal bond failure which has resulted in peeling of the bond and/or detachment of the distal end of the scoring element. May result in vessel injury or embolism.

## 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/K080151
Methodology: https://510kreport.com/methodology