# K972290: Acs HI-Torque Ruler Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Sep 17, 1997 after 90 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 K942066 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942066: Acs HI-Torque Extra S'port Guide Wire, Advanced Cardiovascular Systems, Inc. (1994) Summary page 3.
- K950156: Acs HI-Torque Extra S'port (TM) Guide Wire, Advanced Cardiovascular Systems, Inc. (1995) Summary page 3.

## Indications for use
The ACS HI-TORQUE RULER™ Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), or percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of equipment, such as compatible stent devices, during other diagnostic and therapeutic intravascular procedures. It should not be used with atherectomy devices. It is not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K972290
Methodology: https://510kreport.com/methodology