K-number	K013919
Device name	TORFLEX TRANSSEPTAL GUIDING SHEATH
Applicant	Baylis Medical Co., Inc.
Product code	DBY
Device class	Class I
Decision date	Feb 22, 2002
Decision	Substantially Equivalent
Regulation	866.5520

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View the full FDA submission: accessdata.fda.gov

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TORFLEX TRANSSEPTAL GUIDING SHEATH

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