# K030019: Modification to HI-Torque Whisper Guidewire

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Jan 24, 2003 after 21 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: 3 generations back to K002206 (2000). 3 ancestors in all.
10 later devices descend from it; 4 cite it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020340: Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic Coating, Guidant Corp. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K021287: Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT, Medtronic Perfusion Systems (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K083094: Streamer Polymer Guidewire (2009), 3 descendants of its own
- K061453: HI-Torque Whisper View Guide Wire (2006), 3 descendants of its own
- K103377: Charter Guidewire Model 45-281, 45-282, 45-283 (2011), 2 descendants of its own
- K090554: Acuity Mailman and Strait-Trak Guidewire (2009), 1 descendant of its own
- K063210: Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488 (2007), 1 descendant of its own

## Indications for use
The HI-TORQUE WHISPER 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/K030019
Methodology: https://510kreport.com/methodology