Pure Global
170358
II
current

Catheters, Vascular, Angioplasty, Atherectomyๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ฒฅๆ ทๆ–‘ๅˆ‡้™คๆœฏ

This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, 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: Catheters, Vascular, Angioplasty, Atherectomy

็”ขๅ“่ณ‡่จŠ๏ผš ๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็ฒฅๆ ทๆ–‘ๅˆ‡้™คๆœฏ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
17519
Product Code Detail
17519 Catheters, Vascular, Angioplasty, Atherectomy
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Volcano AtheroMed Inc.
Volcano AtheroMed Inc.
United States
็พŽๅ›ฝ
1530 O'Brien Drive, Suite A, Menlo Park, California, 94025, USA
1530 O'Brien Drive, Suite A, ้—จๆด›ๅธ•ๅ…‹, ๅŠ ๅˆฉ็ฆๅฐผไบšๅทž, 94025, ็พŽๅ›ฝ
Authorised Representative (AR)
Kerry Medical Limited
ๅ˜‰้‡ŒๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
26753700/27645208
Regulatory Timeline
Registration Date
January 12, 2023
Expiry Date
January 12, 2028
Product Models
Phoenix Atherectomy System (P18130, P22130, P18149, P22149, PD24127, P00633)
ๅ‡คๅ‡ฐๅŸŽ็‰™้พˆๅˆ‡้™คๆœฏ็ณป็ปŸ(P18130, P22130, P18149, P22149, PD24127, P00633)