Scimed 8 Fr. Triguideflex Guiding Catheters

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

510(k) Number

K913830 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

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 function of the Scimed 8 Fr. Triguideflex Guiding Catheter?

  This device is a flexible tube designed to navigate the vascular system. It provides the necessary support and stability to facilitate the introduction and accurate placement of interventional devices, such as balloons or stents, during clinical procedures.

• How is this catheter introduced into the patient?

  The Triguideflex is a percutaneous catheter. It is introduced into a vein or artery through the skin using a dilator in conjunction with a sheath or guide wire to ensure proper access to the vascular site.

• What is the regulatory status of this device?

  The Scimed 8 Fr. Triguideflex Guiding Catheters have received FDA 510(k) clearance under the identifier K913830. This indicates the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.