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Axium Detachable Coil System QC-5-10-3D

by Micro Therapeutics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00847536037809 UDI-DI Date15 Aug 2020ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0873-2012 FDA Unclassified (pre-2012) initiated 1 Mar 2010
    • Terminated Z-0874-2012 FDA Unclassified (pre-2012) initiated 1 Mar 2010

    ev3 has initiated a voluntary removal of two lots of Axium Detachable Coil System for product mislabeling as the lots were swapped in production.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Axium Detachable Coil System
Generic Name
Neurovascular embolization coil
Model / Reference
QC-5-10-3D
Primary DI / UDI-DI
00847536037809
510(k) Number
FDA Product Code
KRD, HCG
GMDN Term
Neurovascular embolization coil
Device Class
Class II
Regulation Number
870.3300, 882.5950
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Neurovascular embolization coil

Cleared under the same submission (K081465)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No