K-number	K970466
Device name	RADIUS PTCA GUIDEWIRE
Applicant	Radius Medical Technologies, Inc.
Product code	LIT
Device class	Class II
Decision date	May 20, 1997
Decision	Substantially Equivalent
Regulation	870.1250

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View the full FDA submission: accessdata.fda.gov

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RADIUS PTCA GUIDEWIRE

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