Luge Guide Wire

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K973945 ↗

FDA Product Code

DQX

Device Class

Class II

Regulation

21 CFR Part 870.1330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Triguide Guide Catheters

  Class II

  FDA 510(k) K953515 Active Cleared 19 Sep 1995

• Scimed Viper

  Class II

  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

  Class II

  FDA 510(k) K914312 Active Cleared 22 Nov 1991

• Scimed Triguide Guide Catheter

  Class II

  FDA 510(k) K944537 Active Cleared 21 Oct 1994

• Scimed Pursuit Exchange Ptca Guide Wire

  Class II

  FDA 510(k) K945159 Active Cleared 30 Dec 1994

• Scimed(R) Controlwire(Tm) Guide Wire

  Class II

  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What is the Luge Guide Wire used for?

  The Luge Guide Wire is a flexible, coiled intravascular device designed to navigate blood vessels and facilitate the placement or exchange of therapeutic catheters during percutaneous transluminal coronary angioplasty (PTCA) or other interventional procedures. Its primary function is to provide mechanical support and torque control for catheter delivery in complex coronary anatomy.

• How is the Luge Guide Wire supplied and is it reusable?

  The Luge Guide Wire is supplied as a sterile, single-use product. It is intended for one-time use only in controlled clinical settings such as cardiac catheterization labs and must not be reused or resterilized.

• What compatibility requirements must be met when using the Luge Guide Wire?

  The Luge Guide Wire must be used with interventional devices that have an inner lumen diameter greater than 0.015 inches. It is restricted to use by authorized medical personnel in appropriate clinical environments.

• What regulatory pathway was used for the Luge Guide Wire’s market authorization?

  The Luge Guide Wire received FDA 510(k) clearance under the Traditional pathway, with clearance number K973945, and was found substantially equivalent to a predicate device. It is classified under the Cardiovascular advisory committee.