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Axium Detachable Coil; Axium Prime Detachable Coil

by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

510(k) K203432

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK203432 Date7 Jul 2021ClearedStatusActive

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

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  • Withdrawn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

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