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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 K020998
Device Name SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Applicant Contact GARRY COURTNEY
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
125 BLUE BALL RD.
ELKTON,  MD  21921
Correspondent Contact GARRY COURTNEY
Regulation Number870.4360
Classification Product Code
KFM  
Date Received03/28/2002
Decision Date 04/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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