# K013092: HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Dec 13, 2001 after 87 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 K002206 (2000). 1 ancestor in all.
33 later devices descend from it; 2 cite it directly.
2 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002206: HI-Torque Whisper LS Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper MS Guide Wire with Hydrocoat Hydro, Guidant Corp. (2000) Summary page 1.

## Most influential descendants
- K020340: Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic Coating (2002), 32 descendants of its own
- K030549: HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Pilot 150 Guide Wire with Hydrocoat Hydrophg (2003), 18 descendants of its own
- K101116: HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper LS and MS Guide Wire with (2010), 10 descendants of its own
- K030019: Modification to HI-Torque Whisper Guidewire (2003), 10 descendants of its own
- K091825: HI-Torque Progress Guide Wire Family (2009), 9 descendants of its own

## Indications for use
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

Source page: https://510kreport.com/device/K013092
Methodology: https://510kreport.com/methodology