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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K021210
Device Name ARTERIA OCCLUSION BALLOON
Applicant
Arteria Medical Science, Inc.
22 Hill St.
Newburyport,  MA  01950
Applicant Contact ALAN HINTON
Correspondent
Arteria Medical Science, Inc.
22 Hill St.
Newburyport,  MA  01950
Correspondent Contact ALAN HINTON
Regulation Number870.4450
Classification Product Code
MJN  
Date Received04/17/2002
Decision Date 10/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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