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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K070502
Device Name RADIUS SNARE
Applicant
RADIUS MEDICAL TECHNOLOGIES, INC.
15 CRAIG RD.
ACTON,  MA  01720
Applicant Contact RICHARD DEMELLO
Correspondent
RADIUS MEDICAL TECHNOLOGIES, INC.
15 CRAIG RD.
ACTON,  MA  01720
Correspondent Contact RICHARD DEMELLO
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/21/2007
Decision Date 10/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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