Acs Hi-Torque Ruler Guide Wire
by Guidant Corp. 510(k)
Active
510(k) K972290
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK972290 | Date17 Sep 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Acs Hi-Torque Ruler Guide Wire is a cardiovascular device used to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA). It is also used to facilitate the placement of equipment, such as compatible stent devices, during other diagnostic and therapeutic intravascular procedures.
The device is supplied with a product code of DQX and is cleared through the Traditional 510(k) pathway. It has received FDA 510(k) clearance, indicated by the authorization number K972290. The device is a Class 2 cardiovascular device, and its storage and handling requirements are not specified in the provided data.
Other devices from Guidant Corp.
Questions
AI-generated answers, 25 Sep 2026
What is the Acs Hi-Torque Ruler Guide Wire used for?
The Acs Hi-Torque Ruler Guide Wire is used to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA), and to place equipment like compatible stent devices during other diagnostic and therapeutic intravascular procedures.
How is the device supplied?
The device is supplied with a product code of DQX.
What is the regulatory status of the Acs Hi-Torque Ruler Guide Wire?
The device has received FDA 510(k) clearance, indicated by the authorization number K972290, through the Traditional 510(k) pathway.