K-number	K241720
Device name	VersaCross Connect Transseptal Dilator
Applicant	Baylis Medical Company, Inc.
Product code	DRE
Device class	Class II
Decision date	Jul 12, 2024
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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VersaCross Connect Transseptal Dilator

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VersaCross Connect Transseptal Dilator