# K012534: HI-Torque Middle Support .012 Guide Wire with Hydrocoat Hydrophilic Coating

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Cardiovascular Systems, Inc.
- Decided: Jan 24, 2002 after 171 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACS HI-TORQUE TRAVERSE® Guide Wire with HYDROCOAT™ Hydrophilic Coating: named in the summary without a submission number
- (no number) HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wire with HYDROCOAT™ Hydrophilic Coating: named in the summary without a submission number

## 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/K012534
Methodology: https://510kreport.com/methodology