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510(k) K240871

Synxess Neurovascular Guidewire by Enlight Medical Technologies (Shenzhen) Co., Ltd. — Product Code MOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2024
Date Received
March 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Wire, Catheter, Neurovasculature
Device Class
Class II
Regulation Number
870.1330
Review Panel
NE
Submission Type

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