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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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