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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K020997
Device Name APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
Applicant
DIDECO S.P.A.
195 WEST ST.
WALTHAM,  MA  02451 -1163
Applicant Contact BARRY SALL
Correspondent
DIDECO S.P.A.
195 WEST ST.
WALTHAM,  MA  02451 -1163
Correspondent Contact BARRY SALL
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received03/28/2002
Decision Date 04/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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