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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 6 of 6 Results
ProductCode: DYG Applicant: AMERICAN EDWARDS LABORATORIES Decision Date To: 05/02/2024
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swan-ganz bipolar pacing catheter AMERICAN EDWARDS LABORATORIES K822723 10/15/1982
swan-ganz flow-directed thermodil. cath AMERICAN EDWARDS LABORATORIES K822350 08/24/1982
swan-ganz vip-catheter AMERICAN EDWARDS LABORATORIES K820222 02/12/1982
swan-ganz & edslab heparin coated cath. AMERICAN EDWARDS LABORATORIES K812563 09/25/1981
swan-ganz flow-directed thermodilution AMERICAN EDWARDS LABORATORIES K810352 03/27/1981
swan-ganz vip thermodilution catheter AMERICAN EDWARDS LABORATORIES K810124 02/04/1981
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