Scimed 6-10 F Triguide Guide Catheters 6F, 7F, 8F, 9F & 10F

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

510(k) Number

K961280 ↗

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 Scimed 6-10 F Triguide Guide Catheter used for?

  The Scimed 6-10 F Triguide Guide Catheter is designed for use in cardiovascular procedures as a percutaneous guide catheter, intended to facilitate the delivery of other devices during interventions based on its substantially equivalent design to previously marketed devices.

• What sizes are available for the Scimed 6-10 F Triguide Guide Catheter?

  The Scimed 6-10 F Triguide Guide Catheter is supplied in five sizes: 6F, 7F, 8F, 9F, and 10F, allowing clinicians to select the appropriate diameter based on patient anatomy and procedural requirements.

• Is the Scimed 6-10 F Triguide Guide Catheter sterile and single-use?

  While the device data does not explicitly state sterility or single-use status, as a percutaneous guide catheter cleared via FDA 510(k) for cardiovascular use, it is intended to be supplied sterile and designed for single-use only to prevent cross-contamination and ensure patient safety during procedures.

• How was the Scimed 6-10 F Triguide Guide Catheter cleared for market?

  The Scimed 6-10 F Triguide Guide Catheter received FDA 510(k) clearance (K961280) on May 15, 1996, based on a determination of substantial equivalence to legally marketed predicate devices in terms of intended use, design, and in-vitro testing performance.

• What regulatory classification does the Scimed 6-10 F Triguide Guide Catheter have?

  The device is classified under product code DQY as a Class II medical device, which subjects it to special controls in addition to general controls to ensure safety and effectiveness for its intended use in cardiovascular procedures.