Skip to content

The Trufill DCS Detachable Coil System; The Trufill DCS Orbit Detachable Coil System

by Cordis Neurovascular, Inc.

510(k) K063254

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063254 Date7 Dec 2006ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HCG
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 882.5950
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Trufill DCS Detachable Coil System and the Trufill DCS Orbit Detachable Coil System are neurovascular embolization devices designed for the endovascular treatment of cerebral aneurysms. They function by deploying detachable platinum coils to achieve occlusion of aneurysms through controlled placement and detachment.

These systems are supplied as non-sterile, reusable components requiring sterilization prior to use. They are intended for use in neurovascular embolization procedures and are regulated under FDA 510(k) clearance K063254, with product code HCG and regulation number 882.5950. The device is classified as Class II and is manufactured by Cordis Neurovascular, Inc.

Other devices from Cordis Neurovascular, Inc.

See all devices from Cordis Neurovascular, Inc. →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Trufill DCS Detachable Coil System used for?

    The Trufill DCS Detachable Coil System is designed for the endovascular treatment of cerebral aneurysms by deploying detachable platinum coils to achieve aneurysm occlusion through controlled placement and detachment.

  • How is the Trufill DCS Detachable Coil System supplied and prepared for use?

    The system is supplied as non-sterile, reusable components that require sterilization prior to use in neurovascular embolization procedures.

  • What regulatory pathway was used for the Trufill DCS Detachable Coil System?

    The Trufill DCS Detachable Coil System received FDA 510(k) clearance under K063254, with product code HCG and regulation number 882.5950, and is classified as a Class II device.