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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Guide, Wire, Catheter, Neurovasculature
510(k) Number K240871
Device Name Synxess Neurovascular Guidewire
Applicant
Enlight Medical Technologies (Shenzhen) Co., Ltd.
5-6/F, Bldg. A, Xinghui Technology Industrial Park
52 Huaning Rd., Xinshi Community, Dalang St., Longhua Distri
Shenzhen,  CN 518109
Applicant Contact Gui Kason
Correspondent
Enlight Medical Technologies (Shenzhen) Co., Ltd.
5-6/F, Bldg. A, Xinghui Technology Industrial Park
52 Huaning Rd., Xinshi Community, Dalang St., Longhua Distri
Shenzhen,  CN 518109
Correspondent Contact Gui Kason
Regulation Number870.1330
Classification Product Code
MOF  
Date Received03/29/2024
Decision Date 11/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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