9 French Large Lumen Triguide Plus Guiding Catheter

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

510(k) Number

K934988 ↗

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 clinical use of the 9 French Large Lumen Triguide Plus Guiding Catheter?

  This device is a percutaneous catheter specifically designed for use in venous stenting procedures. It functions to facilitate the delivery of stents and other therapeutic devices to the intended target site within the venous system.

• Who is the manufacturer of this guiding catheter?

  The 9 French Large Lumen Triguide Plus Guiding Catheter is manufactured by Scimed Life Systems, Inc., located in Plymouth, Minnesota.

• What is the regulatory status of this device?

  This device has received FDA 510(k) clearance under the number K934988. It was determined to be substantially equivalent to other devices in the cardiovascular specialty through a traditional review process.