Pure Global
170005
II
Delisted

Catheters, Vascular, Angioplasty, Direct Laser Ablationๅฏผ็ฎกใ€่ก€็ฎกใ€่ก€็ฎกๆˆๅฝขๆœฏใ€็›ดๆŽฅๆฟ€ๅ…‰ๆถˆ่ž

This profile provides complete Hong Kong MDACS registration information for Catheters, Vascular, Angioplasty, Direct Laser Ablation. 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, Direct Laser Ablation

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
17185
State
N/A
Status
Delisted
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Pure Global
DJ Fang

DJ Fang

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Manufacturer (่ฃฝ้€ ๅ•†)
Spectranetics Corporation
Spectranetics Corporation
United States
็พŽๅ›ฝ
9965 Federal Drive, Colorado Springs, Colorado 80921, USA
็พŽๅ›ฝ็ง‘็ฝ—ๆ‹‰ๅคšๅทž็ง‘็ฝ—ๆ‹‰ๅคšๆ–ฏๆ™ฎๆž—ๆ–ฏๅธ‚่”้‚ฆ้ฉฑๅŠจ9965ๅท๏ผŒ้‚ฎๆ”ฟ็ผ–็ 80921
Authorised Representative (AR)
Innotronik Hong Kong Ltd.
ๆฐธๅˆ›ๅŠ›้ฆ™ๆธฏๆœ‰้™ๅ…ฌๅธ
28776787
Regulatory Timeline
Registration Date
February 01, 2022
Expiry Date
February 01, 2027
Delist Date
January 09, 2024
Remarks
Delisted.
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Product Models
Turbo Elite Laser Atherectomy Catheter (410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-02, 425-011, 425-135-02)