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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K001063
Device Name SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
Applicant
BAXTER HEALTHCARE CORP.
17221 RED HILL AVE.
PO BOX 11150
IRVINE,  CA  92614 -5627
Applicant Contact JASON SMITH
Correspondent
BAXTER HEALTHCARE CORP.
17221 RED HILL AVE.
PO BOX 11150
IRVINE,  CA  92614 -5627
Correspondent Contact JASON SMITH
Regulation Number870.1240
Classification Product Code
DYG  
Date Received04/03/2000
Decision Date 07/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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