Medical Device Division · registration 241037Active

Fortrex 0.035" HP PTA Balloon Catheter (A35HPV04020040, A35HPV04020080, A35HPV04020135, A35HPV04040040, A35HPV04040080, A35HPV04040135, A35HPV04080040, A35HPV04080080, A35HPV04080135, A35HPV04100040, A35HPV04100080, A35HPV04100135, A35HPV05020040, A35HPV05020080, A35HPV05020135, A35HPV05040040, A35HPV05040080, A35HPV05040135, A35HPV05080040, A35HPV05080080, A35HPV05080135, A35HPV05100040, A35HPV05100080, A35HPV05100135, A35HPV06020040, A35HPV06020080, A35HPV06020135, A35HPV06040040, A35HPV06040080, A35HPV06040135, A35HPV06080040, A35HPV06080080, A35HPV06080135, A35HPV06100040, A35HPV06100080, A35HPV06100135, A35HPV07020040, A35HPV07020080, A35HPV07020135, A35HPV07040040, A35HPV07040080, A35HPV07040135, A35HPV07080040, A35HPV07080080, A35HPV07080135, A35HPV07100040, A35HPV07100080, A35HPV07100135, A35HPV08040040, A35HPV08040080, A35HPV08040135, A35HPV08080040, A35HPV08080080, A35HPV08080135, A35HPV08100040, A35HPV08100080, A35HPV08100135, A35HPV09040040, A35HPV09040080, A35HPV09040135, A35HPV09080040, A35HPV09080080, A35HPV09080135, A35HPV10040040, A35HPV10040080, A35HPV10040135, A35HPV10080040, A35HPV10080080, A35HPV10080135, A35HPV12040040, A35HPV12040080, A35HPV12040135, A35HPV12080040, A35HPV12080080, A35HPV12080135)

Hong KongCatheters, Vascular, Angioplasty, Balloon, Peripheral ArteryClass IIMedtronic, Inc.

Verified

Official record identity

MDACS listing number: 241037
Model name: Fortrex 0.035" HP PTA Balloon Catheter (A35HPV04020040, A35HPV04020080, A35HPV04020135, A35HPV04040040, A35HPV04040080, A35HPV04040135, A35HPV04080040, A35HPV04080080, A35HPV04080135, A35HPV04100040, A35HPV04100080, A35HPV04100135, A35HPV05020040, A35HPV05020080, A35HPV05020135, A35HPV05040040, A35HPV05040080, A35HPV05040135, A35HPV05080040, A35HPV05080080, A35HPV05080135, A35HPV05100040, A35HPV05100080, A35HPV05100135, A35HPV06020040, A35HPV06020080, A35HPV06020135, A35HPV06040040, A35HPV06040080, A35HPV06040135, A35HPV06080040, A35HPV06080080, A35HPV06080135, A35HPV06100040, A35HPV06100080, A35HPV06100135, A35HPV07020040, A35HPV07020080, A35HPV07020135, A35HPV07040040, A35HPV07040080, A35HPV07040135, A35HPV07080040, A35HPV07080080, A35HPV07080135, A35HPV07100040, A35HPV07100080, A35HPV07100135, A35HPV08040040, A35HPV08040080, A35HPV08040135, A35HPV08080040, A35HPV08080080, A35HPV08080135, A35HPV08100040, A35HPV08100080, A35HPV08100135, A35HPV09040040, A35HPV09040080, A35HPV09040135, A35HPV09080040, A35HPV09080080, A35HPV09080135, A35HPV10040040, A35HPV10040080, A35HPV10040135, A35HPV10080040, A35HPV10080080, A35HPV10080135, A35HPV12040040, A35HPV12040080, A35HPV12040135, A35HPV12080040, A35HPV12080080, A35HPV12080135)
Registration date: September 20, 2024
Expiry date: September 19, 2029
Source update date: November 20, 2024
Status: Active

Classification

Risk class: Class II
Published category: Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery

Published parties

Registrant / registration holder: Medtronic Hong Kong Medical Limited
Manufacturer: Medtronic, Inc.

Official description

Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery

Additional source fields

AMD nomenclature code: 34317
Traditional Chinese local responsible person: 美敦力香港醫療有限公司
Local responsible person phone: 29191300
Published manufacturer address: 710 Medtronic Parkway, Minneapolis, Minnesota 55432, USA

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.