# K032129: Radius 018 Cougar Wire

- Pathway: 510(k) (Special)
- Applicant: Radius Medical Technologies, Inc.
- Decided: Jul 17, 2003 after 7 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K011287 (2001). 1 ancestor in all.
47 later devices descend from it; 2 cite it directly.
5 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011287: Radius Cougar Wire, Radius Medical Technologies, Inc. (2001)

## Most influential descendants
- K061171: Sequitor Steerable Guidewire, Models SQR18XX and SQR14XX (2006), 36 descendants of its own
- K062192: Ostial Pro Stent Positioning System (2007), 35 descendants of its own
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K100292: Caas Qva 3D, Caas Qca 3D (2010), 13 descendants of its own

## Indications for use
Radius .O18 Cougar Wire is intended for placement of balloon dilatation catheters during PTCA andor PTA.

Source page: https://510kreport.com/device/K032129
Methodology: https://510kreport.com/methodology