K-number	K122926
Device name	SUREFLEX STEERABLE GUIDING SHEATH KIT
Applicant	Baylis Medical Co., Inc.
Product code	DYB
Device class	Class II
Decision date	Jan 24, 2013
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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SUREFLEX STEERABLE GUIDING SHEATH KIT

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