K-number	K970470
Device name	EVT EXPANDABLE SHEATH
Applicant	Guidant Cardiac and Vascular Surgery
Product code	DRE
Device class	Class II
Decision date	Jul 31, 1997
Decision	Substantially Equivalent
Regulation	870.1310

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View the full FDA submission: accessdata.fda.gov

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EVT EXPANDABLE SHEATH

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