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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filter, blood, cardiopulmonary bypass, arterial line
510(k) Number K022071
Device Name EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000
Original Applicant
EMBOL-X, INC.
645 clyde ave.
mountain view,  CA  94043
Original Contact ed lee
Regulation Number870.4260
Classification Product Code
DTM  
Date Received06/26/2002
Decision Date 02/14/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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