K-number	K201288
Device name	ExpanSure Large Access Transseptal Dilator
Applicant	Baylis Medical Company, Inc.
Product code	DRE
Device class	Class II
Decision date	Jun 12, 2020
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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ExpanSure Large Access Transseptal Dilator

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