K-number	K180620
Device name	Endophys Pressure Sensing Sheath Kit
Applicant	Endophys Holdings, LLC
Product code	DYB
Device class	Class II
Decision date	Oct 12, 2018
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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Endophys Pressure Sensing Sheath Kit

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