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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 K020693
Device Name AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
Original Applicant
EMBOL-X, INC.
645 clyde ave.
mountain view,  CA  94043
Original Contact edwin lee
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/04/2002
Decision Date 09/05/2002
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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