# K103459: Vascutrak Pta Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 13, 2010 after 19 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: 6 generations back to K001134 (2000). 25 ancestors in all.
36 later devices descend from it; 6 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082343: Vascutrak 2, Models: V14 and V18, Ymed, Inc. (2008) Summary page 4.
- K083657: Conquest Pta Balloon Dilatation Catheter, C.R. Bard, Inc. (2008) Summary page 4.
- K072283: Dorado Pta Balloon Dilatation Catheter, Bard Peripheral Vascular, Inc. (2007) Summary page 4.

## Most influential descendants
- K112182: Angiosculpt Pta Scoring Balloon Catheter (2011), 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
- K142983: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating (2015), 16 descendants of its own
- K161384: Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (2016), 13 descendants of its own

## Indications for use
The Vascutrak™ PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arterioveneous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature.

Source page: https://510kreport.com/device/K103459
Methodology: https://510kreport.com/methodology