# K032899: Radius Cougar Wire

- Pathway: 510(k) (Special)
- Applicant: Radius Medical Technologies, Inc.
- Decided: Oct 17, 2003 after 30 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970466 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970466: Radius Ptca Guidewire, Radius Medical Technologies, Inc. (1997) Summary page 1.
- K011287: Radius Cougar Wire, Radius Medical Technologies, Inc. (2001) Summary page 1.

## Most influential descendants
- K140695: Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition Guidewire (2014), 0 descendants of its own

## Recalls of this device
- Oct 21, 2013 · Class I · Z-0266-2014: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
- Oct 21, 2013 · Class I · Z-0261-2014: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

## Indications for use
Radius Cougar Wire is intended for placement of balloon dilatation catheters during PTCA andor PTA.

Source page: https://510kreport.com/device/K032899
Methodology: https://510kreport.com/methodology