120264
IV
current
Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusionๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่ใ็ๆณจ
This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion. 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, Coronary, Perfusion
็ขๅ่ณ่จ๏ผ ๅฏผ็ฎกใ่ก็ฎกใ่ก็ฎกๆๅฝขๆฏใ็ๅใๅ ็ถๅจ่ใ็ๆณจ
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17521
Product Code Detail
17521 Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion
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
July 31, 2027
Product Models
AngioSculpt PTCA Scoring Balloon Catheter (2001-2010, 2001-2015, 2001-2020, 2001-2510, 2001-2515, 2001-2520, 2001-3010, 2001-3015, 2001-3020, 2001-3510, 2001-3515, 2001-3520, 2200-2006, 2200-2010, 2200-2015, 2200-2020, 2200-2506, 2200-2510, 2200-2515, 2200-2520, 2200-3006, 2200-3010, 2200-3015, 2200-3020, 2200-3506, 2200-3510, 2200-3515, 2200-3520)
่ก็ฎก้ๅกPTCA่ฏๅ็ๅๅฏผ็ฎก(2001-2010,2001-2015,2001-2020,2001-2510,2001-2515,2001-2520,2001-3010,2001-3015,2001-3020,2001-3510,2001-3515,2001-3520,2200-2006,2200-2006,2200-2006,2201-2006,2201-2006,2201-3515,2001-3520,2200-2006,2200-2006,2201-2006,2201-3020,2001-3510,2001-3515,2001-3520,2200-2006,2200-2006,22200-2006,22006,2201-3015,2001-3020,2001-3515,2001-3520,2200-2006,2200-2006,22201-2006,2201-2006,2201-3015,2001-3020,2001-3510,2001-3515,2001-3520,2200-2006,220000-2010, 2200-2015, 2200-2020, 2200-2506, 2200-2510, 2200-2515, 2200-2520, 2200-3006, 2200-3010, 2200-3015, 2200-3020, 2200-3506, 2200-3510, 2200-3515, 2200-3520)