K-number	K112541
Device name	Z FLEX-270TM STEERABLE SHEATH
Applicant	Great Batch Medical
Product code	DRA
Device class	Class II
Decision date	Feb 7, 2012
Decision	Substantially Equivalent
Regulation	870.1280

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Source

View the full FDA submission: accessdata.fda.gov

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Z FLEX-270TM STEERABLE SHEATH

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