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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 K974259
Device Name VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
Applicant
EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Applicant Contact R D HIBBERT
Correspondent
EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Correspondent Contact R D HIBBERT
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/13/1997
Decision Date 12/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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