Pure Global
241037
II
current

Catheters, Vascular, Angioplasty, Balloon, Peripheral Arteryๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Šใ€ๅค–ๅ‘จๅŠจ่„‰

This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ƒๅ›Šใ€ๅค–ๅ‘จๅŠจ่„‰

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
34317
Product Code Detail
34317 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Medtronic, Inc.
Medtronic Plc
United States
็พŽๅ›ฝ
710 Medtronic Parkway, Minneapolis, Minnesota 55432, USA
710็พŽๆ•ฆๅŠ›ๅคง่ทฏ,ๆ˜Žๅฐผ้˜ฟๆณขๅˆฉๆ–ฏ,ๆ˜Žๅฐผ่‹่พพๅทž55432,็พŽๅ›ฝ
Authorised Representative (AR)
Regulatory Timeline
Registration Date
September 20, 2024
Expiry Date
September 19, 2029
Product Models
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)
Fortrex 0.035\' HP PTA็ƒๅ›Šๅฏผ็ฎก(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,A35HPV06040040ใ€A35HPV06040080ใ€A35HPV06040135ใ€A35HPV06080040ใ€A35HPV06080080ใ€A35HPV06080135ใ€A35HPV06100040ใ€A35HPV06100080ใ€A35HPV06100135ใ€A35HPV07020040ใ€A35HPV07020080ใ€A35HPV07020135ใ€A35HPV07040040ใ€A35HPV07040080ใ€A35HPV07040135ใ€A35HPV07080040ใ€A35HPV07080080ใ€A35HPV07080135ใ€A35HPV07100040ใ€A35HPV07100080ใ€A35HPV07100135ใ€A35HPV08040040ใ€A35HPV08040080ใ€A35HPV08040135ใ€A35HPV08080040ใ€A35HPV08080080ใ€A35HPV08080135ใ€A35HPV08100040ใ€A35HPV08100080ใ€A35HPV08100135ใ€A35HPV09040040ใ€A35HPV09040080ใ€A35HPV09040135ใ€A35HPV09080040ใ€A35HPV09080080ใ€A35HPV09080135ใ€A35HPV10040040ใ€A35HPV10040080ใ€A35HPV10040135ใ€A35HPV10080040ใ€A35HPV10080080ใ€A35HPV10080135ใ€A35HPV12040040ใ€A35HPV12040080ใ€A35HPV12040135ใ€A35HPV12080040ใ€A35HPV12080080ใ€A35HPV12080135)