# K020854: Modification to Fox Pta Catheter

- Pathway: 510(k) (Special)
- Applicant: Jomed AG
- Decided: Apr 11, 2002 after 27 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: 1 generation back to K000101 (2000). 3 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010838: Fox Pta Catheter, 3.0, 4.0, 5.0, 6.0, 7.0, and 8.0 X 40 MM, Models A14003, A14004, A14005, A14006, A14007, A14008, Jomed AG (2001)
- K000101: RX Viatrac 14 Peripheral Dilatation Catheter, Guidant Corp. (2000)
- K003972: Numed Ghost II Pta Catheters, NuMED, Inc. (2001)

## Most influential descendants
- K033217: Pheron Pta Catheter (2003), 8 descendants of its own
- K072765: Passeo 18 (2007), 7 descendants of its own
- K082933: Passeo-35 Pta Catheter (2008), 5 descendants of its own
- K040954: Fox Plus Pta Catheter (2004), 5 descendants of its own
- K142379: Passeo-35 PTA Catheter (2014), 3 descendants of its own

## Indications for use
The Fox 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.

Source page: https://510kreport.com/device/K020854
Methodology: https://510kreport.com/methodology