Cleared Traditional

Axium Detachable Coil; Axium Prime Detachable Coil

K203432 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology
Jul 2021
Decision
226d
Days
Class 2
Risk

About This 510(k) Submission

K203432 is an FDA 510(k) clearance for the Axium Detachable Coil; Axium Prime Detachable Coil, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on July 7, 2021, 226 days after receiving the submission on November 23, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K203432 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2020
Decision Date July 07, 2021
Days to Decision 226 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCG — Device, Neurovascular Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5950

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