K-number	K230402
Device name	ENROUTE® Transcarotid Neuroprotection System
Applicant	Silk Road Medical
Product code	NTE
Device class	Class II
Decision date	Apr 11, 2023
Decision	Substantially Equivalent
Regulation	870.1250

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Source

View the full FDA submission: accessdata.fda.gov

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ENROUTE® Transcarotid Neuroprotection System

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