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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
Applicant
EDWARDS LIFESCIENCES, LLC.
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Applicant Contact JOHN W SMITH
Correspondent
EDWARDS LIFESCIENCES, LLC.
6864 SOUTH 300 WEST
MIDVALE,  UT  84047
Correspondent Contact JOHN W SMITH
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/19/2000
Decision Date 08/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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