Pure Global
90315
III
Expired.

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
III
Product Code
17519
Product Code Detail
17519 Catheters, Vascular, Angioplasty, Atherectomy
State
Expired.
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
ev3, Inc.
Ev3, Inc.
United States
็พŽๅ›ฝ
3033 Campus Drive, Plymouth, MN 55441, United States
3033ๆ กๅ›ญ้ฉฑๅŠจๅ™จ, ๆ™ฎๅˆฉ่Œ…ๆ–ฏ, MN 55441, ็พŽ
Authorised Representative (AR)
Rapport Medical Science Limited
ๅ‹ๅšๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
37539075
Regulatory Timeline
Registration Date
August 20, 2009
Expiry Date
August 20, 2014
Product Models
SilverHawk Peripheral Plaque Excision System (P4028, P4030, P4033, P4034, P4044, P4052, P4055, P4056, P6014, FG 02550)
้“ถ้นฐๅค–ๅ‘จๆ–‘ๅ—ๅˆ‡้™ค็ณป็ปŸ(P4028ใ€P4030ใ€P4033ใ€P4034ใ€P4044ใ€P4052ใ€P4055ใ€P4056ใ€P6014ใ€FG 02550)