Triguide Guide Catheters

No FDA recalls on record, checked 22 Oct 2026.

Full name

Scimed Triguide Guide Catheters

510(k) Number

K953515 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

• Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating

  Class II

  FDA 510(k) K941895 Active Cleared 24 May 1994

See all devices from Scimed Life Systems, Inc. →

• Are the Triguide Guide Catheters reusable or intended for single-use in procedures?

  The Triguide Guide Catheters are explicitly designed for single-use in clinical settings. This is stated directly in the device description, ensuring sterility and safety for each procedure without risk of cross-contamination.

• What types of procedures are these catheters intended to assist with, and why?

  These catheters are designed for venous procedures, specifically to aid in the precise placement of intravascular stents. Their structural support and access to target vessels enhance procedural accuracy and safety, as outlined in the device description.

• How are the Triguide Guide Catheters supplied, and what does that mean for clinical workflows?

  The catheters are supplied sterile, which means they are pre-packaged and ready for immediate use without additional sterilization steps. This ensures a streamlined workflow and reduces the risk of contamination during procedures.

• What regulatory pathway was followed for FDA clearance of these catheters, and what does that imply about their safety standards?

  The Triguide Guide Catheters were cleared through the FDA 510(k) pathway (K953515), specifically under the Cardiovascular (CV) advisory committee. This indicates they were deemed substantially equivalent to a legally marketed predicate device, meeting established safety and effectiveness standards for guiding catheters in venous procedures.