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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Defoamer, Cardiopulmonary Bypass
510(k) Number K902355
Device Name MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
Applicant
Medtronic Vascular
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Applicant Contact LOWE, PHD
Correspondent
Medtronic Vascular
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Correspondent Contact LOWE, PHD
Regulation Number870.4230
Classification Product Code
DTP  
Date Received05/29/1990
Decision Date 08/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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