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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Catheter
510(k) Number K073559
Device Name 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
Applicant
Edwards Lifesciences Research Medical
6864 S. 300 W.
Midvale,  UT  84047
Applicant Contact JOHN W NICHOLSON
Correspondent
Edwards Lifesciences Research Medical
6864 S. 300 W.
Midvale,  UT  84047
Correspondent Contact JOHN W NICHOLSON
Regulation Number870.1300
Classification Product Code
DQR  
Date Received12/19/2007
Decision Date 01/31/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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