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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Console, Heart-Lung Machine, Cardiopulmonary Bypass
510(k) Number K022947
Device Name ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH
Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Applicant Contact MARK A BUR
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 JACKSON RD.
ANN ARBOR,  MI  48103
Correspondent Contact MARK A BUR
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received09/05/2002
Decision Date 03/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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