K-number	K972570
Device name	HEARTPORT INTRODUCER SHEATH
Applicant	Heartport, Inc.
Product code	DYB
Device class	Class II
Decision date	Oct 1, 1997
Decision	Substantially Equivalent
Regulation	870.1340

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View the full FDA submission: accessdata.fda.gov

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HEARTPORT INTRODUCER SHEATH

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