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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 K940795
Device Name SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
Applicant
Baxter Edwards
17221 Red Hill Ave.
Irvine,  CA  92614
Applicant Contact IRENE PARKER
Correspondent
Baxter Edwards
17221 Red Hill Ave.
Irvine,  CA  92614
Correspondent Contact IRENE PARKER
Regulation Number870.1240
Classification Product Code
DYG  
Date Received02/22/1994
Decision Date 05/24/1994
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
Recalls CDRH Recalls
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