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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
Applicant
Embol-X, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Applicant Contact ED LEE
Correspondent
Embol-X, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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