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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 K897068
Device Name MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR
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 Number870.4350
Classification Product Code
DTZ  
Date Received12/21/1989
Decision Date 08/28/1991
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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