# K101116: HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Whisper LS and MS Guide Wire with

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular-Cardiac Therapies
- Decided: Jun 23, 2010 after 63 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.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030549: HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Pilot 150 Guide Wire with Hydrocoat Hydrophg, Guidcorp (2003) Summary page 1.

## Most influential descendants
- K122573: HI-Torque Command Guide Wire Family (2012), 6 descendants of its own
- K123067: Progress Guide Wire Family, Pilot Guide Wire Family (2013), 2 descendants of its own
- K240997: Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (2024), 1 descendant of its own
- K193126: HI-TORQUE InfilTrac Guide Wire Family (2019), 1 descendant of its own
- K152404: Hi-Torque Command 18 Guide Wire (2015), 1 descendant 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). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

Source page: https://510kreport.com/device/K101116
Methodology: https://510kreport.com/methodology