# K113838: Wildcat Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Avinger, Inc.
- Decided: Mar 12, 2012 after 75 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- 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: 9 generations back to K890505 (1989). 47 ancestors in all.
No later device cites it as a predicate yet.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111338: Wildcat Catheter, Avinger, Inc. (2011) Summary page 1.
- K111704: Avinger Wildcat 6F Guidewire Support Catheter and Juicebox, Avinger, Inc. (2011) Summary page 1.

## Indications for use
The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature. The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger Wildcat catheter.

Source page: https://510kreport.com/device/K113838
Methodology: https://510kreport.com/methodology