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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 (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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