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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 K090878
Device Name MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING)
Original Applicant
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson rd.
ann arbor,  MI  48103
Original Contact christina thomas
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/31/2009
Decision Date 04/03/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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