Medical Device Division · registration 180251Active

Micro Therapeutics

Name: Micro Therapeutics — Medical Device Division 180251
Creator: Micro Therapeutics, Inc. DBA ev3 Neurovascular
Keywords: Micro Therapeutics, Micro Therapeutics, 180251, 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: 180251
Model name: Concerto Detachable Coil System (Concerto PGLA Fiber Helix (PV-12-30-HELIX, PV-12-40-HELIX, PV-14-30-HELIX, PV-14-40-HELIX, PV-16-40-HELIX, PV-18-40-HELIX, PV-20-50-HELIX), Concerto Nylon Fiber Helix (NV-2-4-HELIX, NV-2-6-HELIX, NV-2-8-HELIX, NV-3-4-HELIX, NV-3-8-HELIX, NV-4-8-HELIX, NV-4-10-HELIX, NV-5-10-HELIX, NV-5-15-HELIX, NV-5-20-HELIX, NV-6-12-HELIX, NV-6-20-HELIX, NV-7-20-HELIX, NV-7-30-HELIX, NV-8-20-HELIX, NV-8-30-HELIX, NV-9-20-HELIX, NV-9-30-HELIX, NV-10-20-HELIX, NV-10-30-HELIX), Concerto PGLA Fiber 3D (PV-2-2-3D, PV-2-4-3D, PV-2-6-3D, PV-3-4-3D, PV-3-6-3D, PV-3-8-3D, PV-4-8-3D, PV-4-10-3D, PV-4-12-3D, PV-5-10-3D, PV-5-15-3D, PV-6-15-3D, PV-6-20-3D, PV-7-20-3D, PV-7-30-3D, PV-8-20-3D, PV-8-30-3D, PV-9-20-3D, PV-9-30-3D, PV-10-20-3D, PV-10-30-3D, PV-12-40-3D, PV-14-40-3D, PV-16-40-3D, PV-18-40-3D))
Registration date: August 10, 2023
Expiry date: August 06, 2028
Source update date: September 12, 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.