Cleared Special

K151447 - Axium Detachable Coil System (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K151447 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
60d
Days
Class 2
Risk

K151447 is an FDA 510(k) clearance for the Axium Detachable Coil System. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on July 28, 2015 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Micro Therapeutics, Inc. d/b/a ev3 Neurovascular devices

Submission Details

510(k) Number K151447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2015
Decision Date July 28, 2015
Days to Decision 60 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 183
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K151447.
Optima Coil System (OptiOne Coil System)
K254221 · Balt USA, LLC · Jan 2026
Target Detachable Coil
K252694 · Stryker Neurovascular · Dec 2025
InZone IST Detachment System
K251832 · Stryker Neurovascular · Oct 2025
Optima Coil System (Optima Packing Coil System)
K252700 · Balt USA, LLC · Sep 2025
Numen™ Coil Embolization System
K242154 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Sep 2024
Optima Coil System (OptiBlock Line Extension)
K242582 · Balt USA, LLC · Sep 2024