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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 K001371
Device Name CARDEON ASCENDING BALLOON CANNULA (ABC)
Applicant
CARDEON CORP.
10161 BUBB RD.
CUPERTINO,  CA  95014 -4133
Applicant Contact JANE BEGGS
Correspondent
CARDEON CORP.
10161 BUBB RD.
CUPERTINO,  CA  95014 -4133
Correspondent Contact JANE BEGGS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/01/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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