Scimed(R) 0.038 Controlwire(Tm) Peripher Guide Wir

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K926457 ↗

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 primary use of the Scimed 0.038 Controlwire Peripher Guide Wire in medical procedures?

  This guide wire is specifically designed for use as a guidewire within catheters and vascular access devices during peripheral vascular procedures. It helps navigate blood vessels during interventional cardiology and peripheral vascular interventions, ensuring precise placement of catheters in complex or narrow vessels.

• Is the Scimed 0.038 Controlwire Peripher Guide Wire intended for single-use or repeated use?

  The device is explicitly labeled as a single-use item, meaning it should not be reused after one procedure. This classification aligns with standard safety practices for guidewires to prevent contamination and ensure patient safety.

• How should the Scimed 0.038 Controlwire Peripher Guide Wire be stored to maintain its integrity?

  Since the device is non-sterile, it must be stored according to the manufacturer’s guidelines to preserve its condition. Proper storage typically involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended by Scimed Life Systems to prevent damage or degradation before use.

• What regulatory pathway was followed for FDA clearance of this guide wire?

  The device received FDA 510(k) clearance under the Substantially Equivalent (SESE) determination in 1993, classified under Class II – Special Controls for wire, guide, and catheter devices. The review was conducted by the Cardiovascular (CV) Advisory Committee, confirming its compliance with existing safety and performance standards for peripheral vascular guidewires.