HSA · registration DE0510413

Micro Therapeutics Axium™ Detachable Coil System

Name: Micro Therapeutics Axium™ Detachable Coil System — HSA DE0510413
Creator: Micro Therapeutics, Inc. d/b/a EV3 Neurovascular
Keywords: Micro Therapeutics Axium™ Detachable Coil System, Micro Therapeutics Axium™ Detachable Coil System, DE0510413, Neurology, HSA

SingaporeNeurologyClass DMicro Therapeutics, Inc. d/b/a EV3 Neurovascular

Verified

Official record identity

Registration number: DE0510413
Model name: Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (Nylon Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix); Axium™ Detachable Coil System (PGLA 3D); Axium™ Detachable Coil System (PGLA Helix)
Model identifier: NC-2-1-HELIX; NC-2-2-HELIX; NC-2-3-HELIX; NC-2-4-HELIX; NC-2-6-HELIX; NC-2-8-HELIX; NC-3-4-HELIX; NC-3-6-HELIX; NC-3-8-HELIX; NC-4-10-HELIX; NC-4-8-HELIX; PC-10-20-3D; PC-10-20-HELIX; PC-10-30-3D; PC-10-30-HELIX; PC-12-30-3D; PC-12-40-3D; PC-14-30-3D; PC-14-40-3D; PC-16-40-3D; PC-18-40-3D; PC-2-1-HELIX; PC-2-2-3D; PC-2-2-HELIX; PC-2-3-HELIX; PC-2-4-3D; PC-2-4-HELIX; PC-2-6-3D; PC-2-6-HELIX; PC-2-8-HELIX; PC-3-4-3D; PC-3-4-HELIX; PC-3-6-3D; PC-3-6-HELIX; PC-3-8-3D; PC-3-8-HELIX; PC-4-10-3D; PC-4-10-HELIX; PC-4-12-3D; PC-4-12-HELIX; PC-4-6-3D; PC-4-8-3D; PC-4-8-HELIX; PC-5-10-3D; PC-5-15-3D; PC-5-15-HELIX; PC-5-20-HELIX; PC-5-8-3D; PC-6-10-3D; PC-6-15-3D; PC-6-20-3D; PC-6-20-HELIX; PC-7-15-3D; PC-7-20-3D; PC-7-20-HELIX; PC-7-30-3D; PC-7-30-HELIX; PC-8-15-3D; PC-8-20-3D; PC-8-20-HELIX; PC-8-30-3D; PC-8-30-HELIX; PC-9-20-3D; PC-9-20-HELIX; PC-9-30-3D; PC-9-30-HELIX
Registration date: March 03, 2025
Source update date: January 13, 2026

Classification

Risk class: Class D
Published category: Neurology

Published parties

Product owner: Micro Therapeutics, Inc. d/b/a EV3 Neurovascular
Registrant / registration holder: COVIDIEN PRIVATE LIMITED

Official description

Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Additional source fields

Product owner address: 9775 Toledo Way,, Irvine, CA. 92618, United States
Registrant address: 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.