FDA 510(k) Applications Submitted by JOCELYN KERSTEN

FDA 510(k) Number Submission Date Device Name Applicant
K210036 01/06/2021 Carnation Ambulatory Monitor (CAM) Bardy Diagnostics, Inc.
K060084 01/11/2006 LYSUS INFUSION SYSTEM EKOS CORP.
K140151 01/22/2014 EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT BTG INTERNATIONAL, INC.
K000409 02/08/2000 MODIFICATION TO T-REX BIOPSY FORCEPS BOSTON SCIENTIFIC CORP.
K080392 02/13/2008 EndoWave Infusion System EKOS CORP.
K060422 02/17/2006 LYSUS INFUSION SYSTEM EKOS CORP.
K050472 02/24/2005 LYSUS INFUSION SYSTEM EKOS CORP.
K030637 02/28/2003 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP.
K050563 03/04/2005 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP.
K200870 04/01/2020 Carnation Ambulatory Monitor Bardy Diagnostics, Inc
K051225 05/12/2005 EKOS MICRO-INFUSION SYSTEM EKOS CORP.
K051319 05/20/2005 LYSUS INFUSION SYSTEM EKOS CORP.
K081467 05/27/2008 EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION EKOS CORP.
K041629 06/16/2004 LYSUS INFUSION SYSTEM EKOS CORP.
K111705 06/17/2011 EKOSONIC ENDOVASCULAR SYSTEM EKOS CORPORATION
K041826 07/07/2004 EKOS ULTRASOUND INFUSION SYSTEM EKOS CORP.
K071933 07/13/2007 ENDOWAVE INFUSION SYSTEM EKOS CORP.
K052071 08/01/2005 LYSUS INFUSION SYSTEM EKOS CORP.
K062507 08/28/2006 MICRO-INFUSION SYSTEM EKOS CORP.
K062508 08/28/2006 NEUROWAVE MICRO-INFUSION SYSTEM EKOS CORP.
K072507 09/06/2007 ENDOWAVE INFUSION SYSTEM EKOS CORP.
K042456 09/10/2004 Lysus Infusion System EKOS CORP.
K192556 09/17/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc
K033214 10/03/2003 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP.
K973818 10/07/1997 T-REX BIOPSY FORCEPS BOSTON SCIENTIFIC CORP.
K003398 11/01/2000 WIRECLIP TORQUER BOSTON SCIENTIFIC CORPORATION NORTHWEST TECHNOLOGY
K073166 11/09/2007 ENDOWAVE INFUSION SYSTEM EKOS CORP.
K043269 11/26/2004 Lysus Infusion System EKOS CORP.
K063620 12/05/2006 EKOS MICRO-INFUSION SYSTEM EKOS CORP.
K053432 12/09/2005 EKOS MICRO-INFUSION SYSTEM EKOS CORP.
K053437 12/09/2005 EKOS MICRO-INFUSION SYSTEM EKOS CORP.


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