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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 K933014
Device Name LIFESTREAM CENTRIFUGEL PUMP INTERFACE #210PI
Applicant
St. Jude Medical, Inc.
12 Elizabeth Dr.
Chelmsford,  MA  01824
Applicant Contact JOSEPH MAGLIOZZI
Correspondent
St. Jude Medical, Inc.
12 Elizabeth Dr.
Chelmsford,  MA  01824
Correspondent Contact JOSEPH MAGLIOZZI
Regulation Number870.4360
Classification Product Code
KFM  
Date Received06/21/1993
Decision Date 09/28/1994
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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