160435
IV
current
Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Deliveryๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅคๅจๅจ่ใ่ฏ็ฉ่พ้
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery. 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, Drug Delivery
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
34320
Product Code Detail
34320 Catheters, Vascular, Angioplasty, Balloon, Peripheral Artery, Drug Delivery
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Spectranetics Corporation
Spectranetics Corporation
United States
็พๅฝ
9965 Federal Drive, Colorado Springs, Colorado 80921, USA
9965่้ฆ้ฉฑๅจๅจ,็ง็ฝๆๅคๆฏๆฎๆๆฏ,็ง็ฝๆๅคๅท80921,็พๅฝ
Authorised Representative (AR)
Innotronik Hong Kong Ltd.
ๆฐธๅๅ้ฆๆธฏๆ้ๅ
ฌๅธ
28776787
Regulatory Timeline
Registration Date
May 26, 2021
Expiry Date
December 13, 2026
Product Models
Stellarex 0.035\" OTW Drug-Coated Angioplasty Balloon (A35SX040040080, A35SX040080080, A35SX040120080, A35SX050040080, A35SX050080080, A35SX050120080, A35SX060040080, A35SX060080080, A35SX060120080, A35SX040040135, A35SX040080135, A35SX040120135, A35SX050040135, A35SX050080135, A35SX050120135, A35SX060040135, A35SX060080135, A35SX060120135)
Stellarex 0.035' OTW่ฏ็ฉๆถๅฑ่ก็ฎกๆๅฝขๆฏ็ๅ(A35SX040040080,A35SX040080080,A35SX040120080,A35SX050040080,A35SX050080080,A35SX050120080,A35SX060040080,A35SX060080080,A35SX060120080,A35SX040040135,A35SX040080135,A35SX040120135,A35SX050040135,A35SX050080135,A35SX050120135,A35SX060040135,A35SX060080135,A35SX060120135)