K-number	K131627
Device name	CATHETER INTRODUCER SHEATH
Applicant	Edwards Lifesciences, LLC
Product code	DYB
Device class	Class II
Decision date	Mar 6, 2014
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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CATHETER INTRODUCER SHEATH

Everything you need for a 510(k) submission. Nothing you don't.