K-number	K240871
Device name	Synxess Neurovascular Guidewire
Applicant	Enlight Medical Technologies (Shenzhen) Co., Ltd.
Product code	MOF
Device class	Class II
Decision date	Nov 18, 2024
Decision	Substantially Equivalent
Regulation	870.1330

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Source

View the full FDA submission: accessdata.fda.gov

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Synxess Neurovascular Guidewire

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