K-number	K102948
Device name	TORFLEX TRANSSEPTAL GUIDING SHEATH
Applicant	Baylis Medical Co., Inc.
Product code	DYB
Device class	Class II
Decision date	Apr 1, 2011
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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TORFLEX TRANSSEPTAL GUIDING SHEATH

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