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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 K001565
Device Name STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
Original Applicant
EDWARDS LIFESCIENCES, LLC.
6864 south 300 west
midvale,  UT  84047
Original Contact john w smith
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/19/2000
Decision Date 08/10/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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