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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 K905312
Device Name DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS
Applicant
Baxter Bentley Laboratories, Inc.
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact DONALD A RAIBLE
Correspondent
Baxter Bentley Laboratories, Inc.
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact DONALD A RAIBLE
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/28/1990
Decision Date 01/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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