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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 K062429
Device Name MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
Applicant
Edwards Lifesciences Research Medical
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact KAREN JONES
Correspondent
Edwards Lifesciences Research Medical
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact KAREN JONES
Regulation Number870.4260
Classification Product Code
DTM  
Date Received08/21/2006
Decision Date 09/27/2006
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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