# K142654: Fortrex 0.035 OTW PTA Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Oct 28, 2014 after 40 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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 K001134 (2000). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103322: Evercross 0.035 Otw Pta Dilation Catheter, Ev3, Inc. (2010) Summary page 4.
- K110319: Evercross 0.035 Otw Pta Dilatation Catheter, Ev3, Inc. (2011) Summary page 4.
- K103751: Mustang Balloon Dilatation Catheters, Boston Scientific (2011) Summary page 4.

## Indications for use
The Fortrex™ 0.035” OTW PTA Balloon 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 arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Source page: https://510kreport.com/device/K142654
Methodology: https://510kreport.com/methodology