240277
IV
current
Stents, Vascular, Intracranial Artery, Aneurysm Flow Diversionๆฏๆถใ่ก็ฎกใ้ข ๅ ๅจ่ใๅจ่็ค่กๆตๅๆต
This profile provides complete Hong Kong MDACS registration information for Stents, Vascular, Intracranial Artery, Aneurysm Flow Diversion. 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: Stents, Vascular, Intracranial Artery, Aneurysm Flow Diversion
็ขๅ่ณ่จ๏ผ ๆฏๆถใ่ก็ฎกใ้ข ๅ ๅจ่ใๅจ่็ค่กๆตๅๆต
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
IV
Product Code
35297
Product Code Detail
35297 Stents, Vascular, Intracranial Artery, Aneurysm Flow Diversion
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Stryker Neurovascular
Stryker
United States
็พๅฝ
47900 Bayside Parkway, Fremont, California, 94538, USA
47900 Bayside Parkway, Fremont, California, 94538, ็พๅฝ
Authorised Representative (AR)
Synapse Therapeutics Limited
็พ่ฐทๅป็็งๆๆ้ๅ
ฌๅธ
31881638
Regulatory Timeline
Registration Date
July 23, 2024
Expiry Date
July 22, 2029
Product Models
Surpass Evolve Flow Diverter System (FD25012, FD25013, FD25014, FD25015, FD25016, FD25017, FD25018, FD25019, FD25020, FD32512, FD32513, FD32514, FD32515, FD32516, FD32517, FD32518, FD32519, FD32520, FD32521, FD32522, FD32525, FD32530, FD40012, FD40013, FD40014, FD40015, FD40016, FD40017, FD40018, FD40019, FD40020, FD40021, FD40022, FD40025, FD40030, FD40040, FD45012, FD45013, FD45014, FD45015, FD45016, FD45017, FD45018, FD45019, FD45020, FD45021, FD45022, FD45025, FD45030, FD45040, FD50012, FD50013, FD50014, FD50015, FD50016, FD50017, FD50018, FD50019, FD50020, FD50021, FD50022, FD50025, FD50030, FD50040)
่ถ
่ถ Evolve ๅๆตๅจ็ณป็ป(FD25012ใFD25013ใFD25014ใFD25015ใFD25016ใFD25017ใFD25018ใFD25019ใFD25020ใFD32512ใFD32513ใFD32514ใFD32515ใFD32516ใFD32517ใFD32518ใFD32519ใFD32520ใFD32521ใFD32522ใFD32525ใFD32530ใFD40012ใFD40013ใFD40014 FD40015ใFD40016ใFD40017ใFD40018ใFD40019ใFD40020ใFD40021ใFD40022ใFD40025ใFD40030ใFD40040ใFD45012ใFD45013ใFD45014ใFD45015ใFD45016ใFD45017ใFD45018ใFD45019ใFD45020ใFD45021ใFD45022ใFD45025ใFD45030ใFD45040ใFD50012ใ FD50013ใFD50014ใFD50015ใFD50016ใFD50017ใFD50018ใFD50019ใFD50020ใFD50021ใFD50022ใFD50025ใFD50030ใFD50040)

