200222
IV
current
Angioplasty Systems, Atherectomy่ก็ฎกๆๅฝขๆฏ็ณป็ป,็ฒฅๆ ทไฝๅ้คๆฏ
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
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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
17559
Product Code Detail
17559 Angioplasty Systems, Atherectomy
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Shockwave Medical, Inc.
Shockwave Medical, Inc.
United States
็พๅฝ
5403 Betsy Ross Drive, Santa Clara, California, 95054, USA
5403 Betsy Ross Drive, ๅฃๅ
ๆๆ, ๅ ๅฉ็ฆๅฐผไบๅท, 95054, ็พๅฝ
Authorised Representative (AR)
Kerry Medical Limited
ๅ้ๅป็ๆ้ๅ
ฌๅธ
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)
ๅฒๅปๆณขๅป็จ่ก็ฎกๅ
็ข็ณๆฏ (IVL) ๅ็ๅจๅ่ฟๆฅๅจ็ต็ผ (IVLGCC, IVLGCCD), ๅฒๅปๆณขๅป็จ IVL ่ฟๆฅๅจ็ต็ผ(ๆดๆข) (IVLCC), ๅคๅจ่ก็ฎกๅ
็ข็ณๆฏ (IVL) ๅฏผ็ฎก (ๅฒๅปๆณข M5 IVL ๅฏผ็ฎก (M5IVL3560, M5IVL4060, M5IVL4560, M5IVL5060, M5IVL5560, M5IVL6060, M5IVL6560, M5IVL7060), ๅฒๅปๆณข S4 IVL ๅฏผ็ฎก (S4IVL2540, S4IVL3040, S4IVL3540, S4IVL4040)), ๅฒๅปๆณข C2 ๅ ็ถๅจ่่ก็ฎกๅ
็ข็ณๆฏ (IVL) ๅฏผ็ฎก (C2IVL2512, C2IVL3012, C2IVL3512,C2IVL4012)