# K092286: Fox SV Pta Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: Aug 27, 2009 after 29 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fox sv PTA Catheter: named in the summary without a submission number
- (no number) Fox Cross PTA Catheter: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K092286
Methodology: https://510kreport.com/methodology