# K111338: Wildcat Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Avinger, Inc.
- Decided: Aug 11, 2011 after 91 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: 8 generations back to K890505 (1989). 45 ancestors in all.
17 later devices descend from it; 3 cite it directly.
1 of 63 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102022: Wildcat 6F Guidewire Support Catheter Model W400L and W400S, Avinger, Inc. (2010) Summary page 2.
- K033535: Lumend Frontrunner Cto Catheter and Accessories, Lumend, Inc. (2004) Summary page 2.
- K072776: The Crosser System, Flowcardia, Inc. (2007) Summary page 2.

## Most influential descendants
- K122380: Ocelot System (2012), 14 descendants of its own
- K123532: Ocelot Pixl Catheter (2012), 12 descendants of its own
- K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console (2014), 7 descendants of its own
- K152275: Pantheris System (2015), 6 descendants of its own
- K153460: Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) (2016), 5 descendants of its own

## 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 Cathetcr is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature.

Source page: https://510kreport.com/device/K111338
Methodology: https://510kreport.com/methodology