120264
Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion
导管、血管、血管成形术、球囊、冠状动脉、灌注
Spectranetics Corporation·IV·Hong Kong MDACS·Registered March 22, 2022
Device overview
- Risk class
- IV
- Product code
- 17521
- State
- current
- Status
- N/A
- Product code detail
- 17521 Catheters, Vascular, Angioplasty, Balloon, Coronary, Perfusion
Manufacturer (製造商)
- Name
- Spectranetics CorporationSpectranetics Corporation
- Country
- United States美国
- Address
- 5055 Brandin Court, Fremont, California, 94538, USA5055 Brandin Court, 弗里蒙特, 加利福尼亚州, 94538, 美国
Authorised representative (AR)
- Name
- Innotronik Hong Kong Ltd.永创力香港有限公司
- Phone
- 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)
血管雕塑PTCA评分球囊导管(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)
About this record
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
產品資訊: 导管、血管、血管成形术、球囊、冠状动脉、灌注