K-number	K881088
Device name	ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
Applicant	Devices For Vascular Intervention, Inc.
Product code	LIT
Device class	Class II
Decision date	May 31, 1988
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)

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