# K061453: HI-Torque Whisper View Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Jun 22, 2006 after 28 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: 4 generations back to K002206 (2000). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 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.

## Most influential descendants
- K090554: Acuity Mailman and Strait-Trak Guidewire (2009), 1 descendant of its own
- K110479: Acuity Whisper View Guide Wires (2011), 0 descendants of its own
- K082935: Vision Wire Coronary Guidewire (2008), 0 descendants of its own

## Indications for use
The HI-TORQUE WHISPER VIEW GUIDE WIRE is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

Source page: https://510kreport.com/device/K061453
Methodology: https://510kreport.com/methodology