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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 K932208
Device Name EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM
Applicant
Baxter Healthcare Corp
P.O. Box 19522
Irvine,  CA  92713
Applicant Contact PAUL ZALESKY
Correspondent
Baxter Healthcare Corp
P.O. Box 19522
Irvine,  CA  92713
Correspondent Contact PAUL ZALESKY
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/06/1993
Decision Date 08/09/1994
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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