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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 K933496
Device Name MAXIMA FILTERED HARDSHELL RESERVIOR
Applicant
Medtronic Vascular
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Applicant Contact NORMA L LOWE
Correspondent
Medtronic Vascular
4633 E. Lapalma Ave.
Anaheim,  CA  92807
Correspondent Contact NORMA L LOWE
Regulation Number870.4230
Classification Product Code
DTP  
Date Received07/19/1993
Decision Date 10/15/1993
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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