160037
Dilators, Surgical, Cardiac
扩张器, 手术, 心脏
Spectranetics Corporation·IV·Hong Kong MDACS·Registered April 09, 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联邦驱动器,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
- April 09, 2021
- Expiry date
- February 05, 2026
Product models
TightRail Rotating Dilator Sheath (545-509, 545-511, 545-513), TightRail Mini Rotating Dilator Sheath (540-009, 540-011)
窄轨旋转扩张器护套(545-509、545-511、545-513)、窄轨迷你旋转扩张器护套(540-009、540-011)
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