200222
Angioplasty Systems, Atherectomy
血管成形术系统,粥样体切除术
Shockwave Medical, Inc.·IV·Hong Kong MDACS·Registered September 29, 2022
Device overview
- Risk class
- IV
- Product code
- 17559
- State
- current
- Status
- N/A
- Product code detail
- 17559 Angioplasty Systems, Atherectomy
Manufacturer (製造商)
- Name
- Shockwave Medical, Inc.Shockwave Medical, Inc.
- Country
- United States美国
- Address
- 5403 Betsy Ross Drive, Santa Clara, California, 95054, USA5403 Betsy Ross Drive, 圣克拉拉, 加利福尼亚州, 95054, 美国
Authorised representative (AR)
- Name
- Kerry Medical Limited嘉里医疗有限公司
- Phone
- 26753700/27645208
Regulatory timeline
- Registration date
- September 29, 2022
- Expiry date
- July 15, 2025
Product models
Shockwave Medical Intravascular Lithotripsy (IVL) Generator and Connector Cable (IVLGCC, IVLGCCD), Shockwave Medical IVL Connector Cable (replacement) (IVLCC), Peripheral Intravascular Lithotripsy (IVL) Catheters (Shockwave M5 IVL Catheters (M5IVL3560, M5IVL4060, M5IVL4560, M5IVL5060, M5IVL5560, M5IVL6060, M5IVL6560, M5IVL7060), Shockwave S4 IVL Catheters (S4IVL2540, S4IVL3040, S4IVL3540, S4IVL4040)), Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheters (C2IVL2512, C2IVL3012, C2IVL3512, C2IVL4012)
冲击波医用血管内碎石术 (IVL) 发生器和连接器电缆 (IVLGCC, IVLGCCD), 冲击波医用 IVL 连接器电缆(更换) (IVLCC), 外周血管内碎石术 (IVL) 导管 (冲击波 M5 IVL 导管 (M5IVL3560, M5IVL4060, M5IVL4560, M5IVL5060, M5IVL5560, M5IVL6060, M5IVL6560, M5IVL7060), 冲击波 S4 IVL 导管 (S4IVL2540, S4IVL3040, S4IVL3540, S4IVL4040)), 冲击波 C2 冠状动脉血管内碎石术 (IVL) 导管 (C2IVL2512, C2IVL3012, C2IVL3512,C2IVL4012)
About this record
This profile provides complete Hong Kong MDACS registration information for Angioplasty Systems, Atherectomy. 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: Angioplasty Systems, Atherectomy
產品資訊： 血管成形术系统,粥样体切除术