# K080264: Modification to: Fox Plus Pta Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular-Vascular Solutions
- Decided: Mar 26, 2008 after 54 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: 3 generations back to K000101 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040954: Fox Plus Pta Catheter, Abbott Laboratories, Inc. (2004) Summary page 1.
- K042538: Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Saexxxxxxxxx, Invatec Innovative Technologies (2004) Summary page 1.

## Most influential descendants
- K080925: Fox Plus Pta Catheter (2008), 0 descendants of its own

## Indications for use
The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.

Source page: https://510kreport.com/device/K080264
Methodology: https://510kreport.com/methodology