K-number	K070487
Device name	SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
Applicant	Volcano Corporation
Product code	DXO
Device class	Class II
Decision date	Mar 16, 2007
Decision	Substantially Equivalent
Regulation	870.2870

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View the full FDA submission: accessdata.fda.gov

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SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX

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