Trufill Dcs Orbit Detachable Coil and Trufill Dcs Syringe, Also Known As Trufill Dcs Orbit Detachable Coil System

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

510(k) Number

K032553 ↗

FDA Product Code

HCG

Device Class

Class II

Regulation

21 CFR Part 882.5950

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips

  Class II

  FDA 510(k) K020680 Active Cleared 27 Mar 2002

• Trufill Dcs Syringe

  Class II

  FDA 510(k) K082324 Active Cleared 12 Sep 2008

• Essence Guidewire

  Class II

  FDA 510(k) K955637 Active Cleared 11 Mar 1996

• Agility Steerable Guidewire

  Class II

  FDA 510(k) K991646 Active Cleared 23 Sep 1999

• Trufill Dcs Orbit Detachable Coil System Line Extension

  Class II

  FDA 510(k) K053197 Active Cleared 15 Dec 2005

• Envoy Guiding Catheter

  Class II

  FDA 510(k) K965247 Active Cleared 23 Jul 1997

See all devices from Cordis Neurovascular, Inc. →