# K063210: Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Inc. Cardiac Rhythm Management
- Decided: Mar 15, 2007 after 143 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002206 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030019: Modification to HI-Torque Whisper Guidewire, Guidant Corp. (2003) Summary page 1.
- K010906: Medtronic Stylet Kit, Models 6282, 6293, and 6254, Medtronic Vascular (2001) Summary page 1.
- K983927: GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support, Arterial Vascular Engineering, Inc. (1999) Summary page 1.
- K903923: Usci (R) Silk (TM) Guide Wire, C.R. Bard, Inc. (1990) Summary page 1.

## Most influential descendants
- K143316: Attain Hybrid Guide Wire (2015), 0 descendants of its own

## Recalls of this device
- Oct 21, 2013 · Class I · Z-0265-2014: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

## Indications for use
The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.

Source page: https://510kreport.com/device/K063210
Methodology: https://510kreport.com/methodology