# K040954: Fox Plus Pta Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories, Inc.
- Decided: May 11, 2004 after 28 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: 2 generations back to K000101 (2000). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020854: Modification to Fox Pta Catheter, Jomed AG (2002) Summary page 1.

## Most influential descendants
- K051519: Fox SV Pta Catheter (82XXX Series).   Fox Plus Pta Catheter (12XXX Series) (2005), 2 descendants of its own
- K080264: Modification to: Fox Plus Pta Catheter (2008), 1 descendant of its own
- K062843: Fox SV Pta Catheter (2006), 1 descendant of its own
- K080925: Fox Plus Pta Catheter (2008), 0 descendants of its own
- K072824: Fox SV Pta Catheter (2007), 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/K040954
Methodology: https://510kreport.com/methodology