160127
Dilators, Surgical, Cardiac
扩张器, 手术, 心脏
Spectranetics Corporation·IV·Hong Kong MDACS·Registered March 08, 2021
Device overview
- Risk class
- IV
- Product code
- 11255
- State
- current
- Status
- N/A
- Product code detail
- 11255 Dilators, Surgical, Cardiac
Manufacturer (製造商)
- Name
- Spectranetics CorporationSpectranetics Corporation
- Country
- United States美国
- Address
- 9965 Federal Drive, Colorado Springs, Colorado, 80921, USA9965联邦大道, 科罗拉多斯普林斯, 科罗拉多州, 80921, 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 08, 2021
- Expiry date
- May 25, 2026
Product models
SightRail Manual Mechanical Dilator Sheath Sets (550-008, 550-010, 550-011, 550-013, 555-508, 555-510, 555-511, 555-513)
SightRail 手动机械扩张器护套 (550-008, 550-010, 550-011, 550-013, 555-508, 555-510, 555-511, 555-513)
About this record
This profile provides complete Hong Kong MDACS registration information for Dilators, Surgical, Cardiac. 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: Dilators, Surgical, Cardiac
產品資訊： 扩张器, 手术, 心脏