Medical Device Division · registration 180079Active

Micro Therapeutics

Name: Micro Therapeutics — Medical Device Division 180079
Creator: Micro Therapeutics, Inc. DBA ev3 Neurovascular
Keywords: Micro Therapeutics, Micro Therapeutics, 180079, Occluders, Vascular, Intravascular Embolization, Coil, Medical Device Division

Hong KongOccluders, Vascular, Intravascular Embolization, CoilClass IVMicro Therapeutics, Inc. DBA ev3 Neurovascular

Verified

Official record identity

MDACS listing number: 180079
Model name: Axium Helix (QC-1.5-2-HELIX, QC-2-1-HELIX, QC-2-2-HELIX, QC-2-3-HELIX, QC-2-4-HELIX, QC-2-6-HELIX, QC-2-8-HELIX, QC-3-4-HELIX, QC-3-6-HELIX, QC-1.5-1-HELIX, QC-2.5-4-HELIX, QC-3-8-HELIX, QC-4-8-HELIX, QC-4-10-HELIX, QC-4-12-HELIX, QC-5-15-HELIX, QC-5-20-HELIX, QC-6-20-HELIX, QC-7-20-HELIX, QC-7-30-HELIX, QC-1.5-3-HELIX, QC-2.5-6-HELIX, QC-8-20-HELIX, QC-8-30-HELIX, QC-9-20-HELIX, QC-9-30-HELIX, QC-10-20-HELIX, QC-10-30-HELIX, QC-12-30-HELIX, QC-12-40-HELIX, QC-14-30-HELIX, QC-1.5-4-HELIX, QC-2.5-8-HELIX, QC-14-40-HELIX, QC-16-30-HELIX, QC-16-40-HELIX, QC-18-40-HELIX, QC-20-40-HELIX, QC-20-50-HELIX, QC-2.5-2-HELIX), Axium 3D (QC-2-2-3D, QC-2-4-3D, QC-2-6-3D, QC-3-4-3D, QC-3-6-3D, QC-3-8-3D, QC-4-6-3D, QC-4-8-3D, QC-4-10-3D, QC-2.5-2-3D, QC-3-10-3D, QC-4-12-3D, QC-5-8-3D, QC-5-10-3D, QC-5-15-3D, QC-6-10-3D, QC-6-15-3D, QC-6-20-3D, QC-7-15-3D, QC-7-20-3D, QC-2.5-4-3D, QC-3.5-6-3D, QC-7-30-3D, QC-8-15-3D, QC-8-20-3D, QC-8-30-3D, QC-9-20-3D, QC-9-30-3D, QC-10-20-3D, QC-10-30-3D, QC-12-30-3D, QC-2.5-6-3D, QC-3.5-12-3D, QC-12-40-3D, QC-14-30-3D, QC-14-40-3D, QC-16-40-3D, QC-18-40-3D, QC-20-50-3D, QC-22-50-3D, QC-25-50-3D, QC-2.5-8-3D, QC-3.5-15-3D), Instant Detacher (ID-1-5), Axium PGLA Helix (PC-2-1-HELIX, PC-2-2-HELIX, PC-2-3-HELIX, PC-2-4-HELIX, PC-2-6-HELIX, PC-2-8-HELIX, PC-3-4-HELIX, PC-3-6-HELIX, PC-3-8-HELIX, PC-4-8-HELIX, PC-4-10-HELIX, PC-4-12-HELIX, PC-5-15-HELIX, PC-5-20-HELIX, PC-6-20-HELIX, PC-7-20-HELIX, PC-7-30-HELIX, PC-8-20-HELIX, PC-8-30-HELIX, PC-9-20-HELIX, PC-9-30-HELIX, PC-10-20-HELIX, PC-10-30-HELIX), Axium PGLA 3D (PC-2-2-3D, PC-2-4-3D, PC-2-6-3D, PC-3-4-3D, PC-3-6-3D, PC-3-8-3D, PC-4-6-3D, PC-4-8-3D, PC-4-10-3D, PC-4-12-3D, PC-5-8-3D, PC-5-10-3D, PC-5-15-3D, PC-6-10-3D, PC-6-15-3D, PC-6-20-3D, PC-7-15-3D, PC-7-20-3D, PC-7-30-3D, PC-8-15-3D, PC-8-20-3D, PC-8-30-3D, PC-9-20-3D, PC-9-30-3D, PC-10-20-3D, PC-10-30-3D, PC-12-30-3D, PC-12-40-3D, PC-14-30-3D, PC-14-40-3D, PC-16-40-3D, PC-18-40-3D), Nylon Helix (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-4-8-Helix, NC-4-10-Helix)
Registration date: October 19, 2023
Expiry date: April 16, 2028
Source update date: March 20, 2024
Status: Active

Classification

Risk class: Class IV
Published category: Occluders, Vascular, Intravascular Embolization, Coil

Published parties

Registrant / registration holder: Medtronic Hong Kong Medical Limited
Manufacturer: Micro Therapeutics, Inc. DBA ev3 Neurovascular

Official description

Occluders, Vascular, Intravascular Embolization, Coil

Additional source fields

AMD nomenclature code: 22543
Traditional Chinese local responsible person: 美敦力香港醫療有限公司
Local responsible person phone: 29191300
Published manufacturer address: 9775 Toledo Way, Irvine, CA, 92618, United States of America
Revision number: b

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.