240273
Prostheses, Cardiac Valve
假体、心脏瓣膜
Medtronic CoreValve LLC·IV·Hong Kong MDACS·Registered July 23, 2024
Device overview
- Risk class
- IV
- Product code
- 13138
- State
- current
- Status
- N/A
- Product code detail
- 13138 Prostheses, Cardiac Valve
Manufacturer (製造商)
- Name
- Medtronic CoreValve LLCMedtronic CoreValve LLC
- Country
- United States美国
- Address
- 1851 E. Deere Ave, Santa Ana, CA 92705, USA1851 E.迪尔大道,圣安娜,CA 92705,美国
Authorised representative (AR)
- Phone
- 29191300
Regulatory timeline
- Registration date
- July 23, 2024
- Expiry date
- July 22, 2029
Product models
Evolut FX System (EVOLUTFX-23, EVOLUTFX-26, EVOLUTFX-29, EVOLUTFX-34, D-EVOLUTFX-2329, D-EVOLUTFX-34, L-EVOLUTFX-2329, L-EVOLUTFX-34)
Evolut FX 系统 (EVOLUTFX-23, EVOLUTFX-26, EVOLUTFX-29, EVOLUTFX-34, D-EVOLUTFX-2329, D-EVOLUTFX-34, L-EVOLUTFX-2329, L-EVOLUTFX-34)
About this record
This profile provides complete Hong Kong MDACS registration information for Prostheses, Cardiac Valve. 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: Prostheses, Cardiac Valve
產品資訊： 假体、心脏瓣膜