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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
Recalls CDRH Recalls
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