# K060551: Brivant Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Brivant Limited
- Decided: Jun 7, 2006 after 97 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: 5 generations back to K970376 (1997). 12 ancestors in all.
9 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050756: Skipper and Skipper Race Guidewire, Invatec Innovative Technologies, S.R.L. (2005) Summary page 1.
- K011287: Radius Cougar Wire, Radius Medical Technologies, Inc. (2001) Summary page 1.
- K032129: Radius 018 Cougar Wire, Radius Medical Technologies, Inc. (2003) Summary page 1.

## Most influential descendants
- K083094: Streamer Polymer Guidewire (2009), 3 descendants of its own
- K103377: Charter Guidewire Model 45-281, 45-282, 45-283 (2011), 2 descendants of its own
- K160643: ENROUTE 0.014 Guidewire (2016), 1 descendant of its own
- K102211: Cruiser 18 Guidewire (2010), 1 descendant of its own
- K253746: Enroute 0.014'' Transcarotid Guidewire (2026), 0 descendants of its own

## Indications for use
Brivant guidewires are intended for use in the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K060551
Methodology: https://510kreport.com/methodology