Cleared Traditional

K203432 - Axium Detachable Coil

Also marketed or referenced as:
Axium Prime Detachable Coil

K203432 is the FDA 510(k) clearance for Axium Detachable Coil by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K203432 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
226d
Days
Class 2
Risk

K203432 is an FDA 510(k) clearance for the Axium Detachable Coil. 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 7, 2021 after a review of 226 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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

Submission Details

510(k) Number K203432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 148d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 116
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K203432.
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
K220040 · Medos International SARL · Jul 2022
InZone Detachment System
K212455 · Stryker Neurovascular · Nov 2021
Numen Coil Embolization System
K203625 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Sep 2021
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
K211344 · Medos International SARL · May 2021
i-ED COIL System
K210638 · Kaneka Medical America, LLC · Mar 2021
i-ED COIL
K192068 · Kaneka Pharma America, LLC · Apr 2020