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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K924661
Device Name SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
Applicant
Baxter Healthcare Corp
P.O. Box 11150
Santa Ana,  CA  92711
Applicant Contact FOSS DAVIES
Correspondent
Baxter Healthcare Corp
P.O. Box 11150
Santa Ana,  CA  92711
Correspondent Contact FOSS DAVIES
Regulation Number870.1210
Classification Product Code
KRA  
Date Received09/15/1992
Decision Date 04/08/1993
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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