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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
Applicant
EMBOL-X, INC.
645 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Applicant Contact EDWIN LEE
Correspondent
EMBOL-X, INC.
645 CLYDE AVE.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact EDWIN LEE
Regulation Number870.4210
Classification Product Code
DWF  
Date Received03/04/2002
Decision Date 09/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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