Medical Device Division · registration 160417Active

Micro Therapeutics

Name: Micro Therapeutics — Medical Device Division 160417
Creator: Micro Therapeutics, Inc. DBA ev3 Neurovascular
Keywords: Micro Therapeutics, Micro Therapeutics, 160417, Occluders, Vascular, Intravascular Embolization, Medical Device Division

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

Verified

Official record identity

MDACS listing number: 160417
Model name: Axium Prime Detachable Coil System (APB-4-6-HX-SS, APB-4-8-HX-SS, APB-4-10-HX-SS, APB-4-12-HX-SS, APB-5-10-HX-SS, APB-5-15-HX-SS, APB-5-20-HX-SS, APB-6-12-HX-SS, APB-6-20-HX-SS, APB-1-1-HX-ES, APB-1-2-HX-ES, APB-1-3-HX-ES, APB-1.5-1-HX-ES, APB-1.5-2-HX-ES, APB-1.5-3-HX-ES, APB-1.5-4-HX-ES, APB-2-1-HX-ES, APB-2-2-HX-ES, APB-2-3-HX-ES, APB-2-4-HX-ES, APB-2-6-HX-ES, APB-2-8-HX-ES, APB-2.5-3-HX-ES, APB-2.5-4-HX-ES, APB-2.5-6-HX-ES, APB-2.5-8-HX-ES, APB-3-4-HX-ES, APB-3-6-HX-ES, APB-3-8-HX-ES, APB-3-10-HX-ES, APB-4-6-3D-SS, APB-4-8-3D-SS, APB-4-10-3D-SS, APB-4-12-3D-SS, APB-5-8-3D-SS, APB-5-10-3D-SS, APB-5-15-3D-SS, APB-6-10-3D-SS, APB-6-15-3D-SS, APB-6-20-3D-SS, APB-1-2-3D-ES, APB-1-3-3D-ES, APB-1-4-3D-ES, APB-1.5-2-3D-ES, APB-1.5-3-3D-ES, APB-1.5-4-3D-ES, APB-2-2-3D-ES, APB-2-3-3D-ES, APB-2-4-3D-ES, APB-2.5-4-3D-ES, APB-2.5-6-3D-ES, APB-3-4-3D-ES, APB-3-6-3D-ES, APB-3-8-3D-ES, APB-3.5-6-3D-ES, APB-3.5-8-3D-ES, APB-3.5-10-3D-ES, FC-3-6-3D, FC-3-8-3D, FC-3-10-3D, FC-3.5-6-3D, FC-3.5-8-3D, FC-3.5-10-3D, FC-4-6-3D, FC-4-8-3D, FC-4-10-3D, FC4-12-3D, FC-4-15-3D, FC-5-8-3D, FC-5-10-3D, FC-5-15-3D, FC-5-20-3D, FC-6-10-3D, FC-6-15-3D, FC-6-20-3D, FC-6-25-3D, FC-7-12-3D, FC-7-15-3D, FC-7-20-3D, FC-7-30-3D, FC-8-15-3D, FC-8-20-3D, FC-8-30-3D, FC-9-20-3D, FC-9-30-3D, FC-10-20-3D, FC-10-30-3D, FC-10-40-3D, FC-12-30-3D, FC-12-40-3D, FC-12-50-3D, FC-14-30-3D, FC-14-40-3D, FC-14-50-3D, FC-16-40-3D, FC-16-50-3D, FC-18-40-3D, FC-18-50-3D, FC-20-50-3D, FC-22-50-3D, FC-25-50-3D)
Registration date: June 18, 2026
Expiry date: December 04, 2031
Source update date: August 12, 2026
Status: Active

Classification

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

Published parties

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

Official description

Occluders, Vascular, Intravascular Embolization

Additional source fields

AMD nomenclature code: 15034
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: d

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.