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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K991864
Device Name ROTAFLOW CENTRIFUGAL PUMP SYSTEM
Applicant
JOSTRA MEDIZINTECHNIK AG
2035 SUNSET LAKE RD.
NEWARK,  DE  19702
Applicant Contact KATHY JOHNSON
Correspondent
JOSTRA MEDIZINTECHNIK AG
2035 SUNSET LAKE RD.
NEWARK,  DE  19702
Correspondent Contact KATHY JOHNSON
Regulation Number870.4360
Classification Product Code
KFM  
Date Received06/01/1999
Decision Date 08/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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