K-number	K190688
Device name	VersaCross Steerable Sheath, VersaCross Transseptal Dilator
Applicant	Baylis Medical Company, Inc.
Product code	DYB
Device class	Class II
Decision date	Apr 17, 2019
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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VersaCross Steerable Sheath, VersaCross Transseptal Dilator

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