# K030549: HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Pilot 150 Guide Wire with Hydrocoat Hydrophg

- Pathway: 510(k) (Special)
- Applicant: Guidcorp
- Decided: May 14, 2003 after 82 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.
18 later devices descend from it; 3 cite it directly.
1 of 22 devices in its family (counting itself) has 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.
- K013092: HI-Toque Whisper LS and MS Guide Wire with Hydrocoat Hydrophilic Coating, Guidant Corp. (2001) Summary page 1.
- K020340: Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat Hydrophilic Coating, Guidant Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- K091825: HI-Torque Progress Guide Wire Family (2009), 9 descendants of its own
- K122573: HI-Torque Command Guide Wire Family (2012), 6 descendants of its own
- K101011: HI-Torque Balance Middleweight Universal (2010), 4 descendants of its own
- K152709: HI-Torque Balance (2015), 2 descendants of its own

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

Source page: https://510kreport.com/device/K030549
Methodology: https://510kreport.com/methodology