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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
Recalls CDRH Recalls
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