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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 K894255
Device Name ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP
Applicant
St. Jude Medical, Inc.
825 N 300 W
Salt Lake City,  UT  84103
Applicant Contact TERRY DAHL
Correspondent
St. Jude Medical, Inc.
825 N 300 W
Salt Lake City,  UT  84103
Correspondent Contact TERRY DAHL
Regulation Number870.4360
Classification Product Code
KFM  
Date Received06/20/1989
Decision Date 09/26/1989
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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