# K073025: Vascutrak II Pta Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Thermopeutix, Inc. Dba Ymed, Inc.
- Decided: Nov 9, 2007 after 14 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 K971010 (1997). 5 ancestors in all.
48 later devices descend from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063657: Vascutrak Pta Dilation Catheter, Ymed, Inc. (2006) Summary page 4.

## Most influential descendants
- K082343: Vascutrak 2, Models: V14 and V18 (2008), 47 descendants of its own
- K103459: Vascutrak Pta Dilatation Catheter (2010), 36 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

## Indications for use
The VascuTraK™ II PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K073025
Methodology: https://510kreport.com/methodology