# K063657: Vascutrak Pta Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ymed, Inc.
- Decided: Dec 12, 2006 after 4 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: 1 generation back to K971010 (1997). 4 ancestors in all.
52 later devices descend from it; 3 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042624: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2005) Summary page 4.
- K971010: Peripheral Transluminal Angioplasty Catheters, Cordis Corp. (1997) Summary page 4.
- K000101: RX Viatrac 14 Peripheral Dilatation Catheter, Guidant Corp. (2000)
- K001134: Gazelle Balloon Dilatation Catheter, Boston Scientific Corp (2000) Summary page 4.

## Most influential descendants
- K073025: Vascutrak II Pta Dilatation Catheter (2007), 48 descendants of its own
- 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

## Indications for use
The VascuTraK™ 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/K063657
Methodology: https://510kreport.com/methodology