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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K021441
Device Name RADIUS SNARE
Applicant
RADIUS MEDICAL TECHNOLOGIES, INC.
63 GREAT RD.
MAYNARD,  MA  01754
Applicant Contact MAUREEN FINLAYSON
Correspondent
RADIUS MEDICAL TECHNOLOGIES, INC.
63 GREAT RD.
MAYNARD,  MA  01754
Correspondent Contact MAUREEN FINLAYSON
Regulation Number870.5150
Classification Product Code
MMX  
Date Received05/06/2002
Decision Date 06/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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