# K100303: Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-Xxyy

- Pathway: 510(k) (Traditional)
- Applicant: Angioscore, Inc.
- Decided: Mar 22, 2010 after 47 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: 7 generations back to K971448 (1997). 19 ancestors in all.
32 later devices descend from it; 3 cite it directly.
0 of 52 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.
- K063657: Vascutrak Pta Dilation Catheter, Ymed, Inc. (2006) Summary page 4.
- K082343: Vascutrak 2, Models: V14 and V18, Ymed, Inc. (2008) 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.
- K080151: Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039, Angioscore, Inc. (2008) Summary page 4.
- K081220: Modification to Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2008) Summary page 4.
- K082059: Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2008). Our OCR of the scanned summary read K082058, FDA’s number for Dynamatrix (Cook Biotech, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AngioSculpt Scoring Balloon Catheter”.
- K091966: Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040, Angioscore, Inc. (2009) Summary page 4.

## Most influential descendants
- 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
- K122685: Angiosculpt Pta Scoring Balloon Catheter (2013), 28 descendants of its own
- K133998: Angiosculpt Pta Scoring Balloon with Hydrocross Caoting (2014), 24 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 obstruclive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

Source page: https://510kreport.com/device/K100303
Methodology: https://510kreport.com/methodology