K-number	K153485
Device name	ENROUTE Transcarotid Neuroprotection System
Applicant	Silk Road Medical, Inc.
Product code	NTE
Device class	Class II
Decision date	Mar 10, 2016
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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