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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K970466
Device Name RADIUS PTCA GUIDEWIRE
Applicant
RADIUS MEDICAL TECHNOLOGIES, INC.
63 GREAT RD.
MAYNARD,  MA  01754
Applicant Contact MAUREEN A FINLAYSON
Correspondent
RADIUS MEDICAL TECHNOLOGIES, INC.
63 GREAT RD.
MAYNARD,  MA  01754
Correspondent Contact MAUREEN A FINLAYSON
Regulation Number870.1250
Classification Product Code
LIT  
Date Received02/07/1997
Decision Date 05/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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