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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K911367
Device Name BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
Applicant
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Applicant Contact RONALD H BERGESON
Correspondent
Baxter Healthcare Corp
P O Box 11150
Santa Ana,  CA  92711
Correspondent Contact RONALD H BERGESON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/28/1991
Decision Date 06/10/1991
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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