Axium™ Detachable Coil System PC-2-2-3D

by Micro Therapeutics, Inc. 3 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

This device is named in the recall

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00763000489076 UDI-DI	Date28 Oct 2022Listed	StatusListed GUDID: not in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-1261-2022 FDA Class II initiated 27 Apr 2022
Due to incorrect size and configuration labeling of the detachable coil system.

Coverage

1 jurisdiction

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Withdrawn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: PC-2-2-3D

Primary DI / UDI-DI: 00763000489076
510(k) Number: K203432
FDA Product Code: KRD, HCG
GMDN Term: Neurovascular embolization coil

Device Class: Class II
Regulation Number: 870.3300, 882.5950
GUDID distribution status: Not in Commercial Distribution

MRI Safety: MR Conditional

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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