120171
II
current
Catheters, Vascular, Angioplasty, Balloonๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅ
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon. 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
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
17184
Product Code Detail
17184 Catheters, Vascular, Angioplasty, Balloon
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Spectranetics Corporation
Spectranetics Corporation
United States
็พๅฝ
5055 Brandin Court, Fremont, California, 94538, USA
5055 Brandin Court, ๅผ้่็น, ๅ ๅฉ็ฆๅฐผไบๅท, 94538, ็พๅฝ
Authorised Representative (AR)
Innotronik Hong Kong Ltd.
ๆฐธๅๅ้ฆๆธฏๆ้ๅ
ฌๅธ
28776787
Regulatory Timeline
Registration Date
March 22, 2022
Expiry Date
June 01, 2027
Product Models
AngioSculpt PTA Scoring Balloon Catheter, OTW (2039-2010, 2039-2020, 2039-2520, 2039-3020, 2039-3520, 2076-4020, 2076-4040, 2076-5020, 2076-5040, 2076-6020, 2076-6040, 2092-4040, 2092-5040, 2092-6020, 2092-6040, 2105-6020, 2105-6040, 2155-2040, 2155-2540, 2155-3040, 2155-3540, 2239-2040, 2239-2540, 2239-3040, 2239-3540, 2215-20100, 2215-25100, 2215-30100, 2215-35100, 2216-20100, 2216-25100, 2216-30100, 2216-35100, 2237-40100, 2237-50100, 2237-60100, 2290-40100, 2290-50100, 2290-60100, 2332-7040, 2332-8040, 2333-7040, 2333-8040, 2334-7040, 2334-8040)
่ก็ฎก้ๅกPTA่ฎกๅ็ๅๅฏผ็ฎก,OTW (2039-2010, 2039-2020, 2039-2520, 2039-3020, 2039-3520, 2076-4020, 2076-4040, 2076-5020, 2076-5040, 2076-6020, 2076-6040, 2092-4040, 2092-5040, 2092-6020, 2092-6040, 2105-6020, 2105-6040, 2155-2040, 2155-2540, 2155-21540, 215 5-3040, 2155-3540, 2239-2040, 2239-2540, 2239-3040, 2239-3540, 2215-20100, 2215-25100, 2215-30100, 2215-35100, 2216-20100, 2216-25100, 2216-30100, 2216-35100, 2237-40100, 2237-50100, 2237-60100, 2290-40100, 2290-50100, 2290-60100,2332-7040, 2332-8040, 2333-7040, 2333-8040, 2334-7040, 2334-8040)