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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 K972503
Device Name CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
Applicant
CALIFORNIA MEDICAL LABORATORIES, INC.
2681 KELVIN AVE.
IRVINE,  CA  92614
Applicant Contact MEHMET BICAKCI
Correspondent
CALIFORNIA MEDICAL LABORATORIES, INC.
2681 KELVIN AVE.
IRVINE,  CA  92614
Correspondent Contact MEHMET BICAKCI
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/03/1997
Decision Date 08/26/1997
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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