K-number	K231227
Device name	SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
Applicant	Baylis Medical Company, Inc.
Product code	DYB
Device class	Class II
Decision date	Dec 20, 2023
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath

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