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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K080034
Device Name THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
Original Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson rd.
ann arbor,  MI  48103
Original Contact andrea wallen
Regulation Number870.4210
Classification Product Code
DWF  
Date Received01/07/2008
Decision Date 06/17/2008
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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