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Acs Hi-Torque Ruler Guide Wire

by Guidant Corp. 510(k)

Active United States

510(k) K972290

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972290 Date17 Sep 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • 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.