FDA 510(k) Applications Submitted by CareFusion

FDA 510(k) Number Submission Date Device Name Applicant
K231888 06/27/2023 BD TexiumÖ Needle-Free Syringe Carefusion
K223076 09/30/2022 BD TexiumÖ Closed Male Luer CareFusion
K120518 02/21/2012 END TIDAL CO2 NASAL CANNULA CAREFUSION
K151303 05/18/2015 AirLife Infant Heated Wire Circuit CAREFUSION
K123527 11/16/2012 AIRLIFE CAREFUSION
K153748 12/29/2015 AirLife Misty Finity Nebulizer CareFusion
K103211 11/01/2010 AVEA VENTILATOR CAREFUSION
K223088 09/30/2022 BD SmartSiteÖ Needle-Free Connector CareFusion
K160450 02/18/2016 Pleurx Pleural Catheter System CAREFUSION
K150523 03/02/2015 AVAmax Vertebral Balloon CAREFUSION
K151125 04/28/2015 AVAflex Vertebral Balloon System CAREFUSION
K141552 06/11/2014 ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS CAREFUSION
K131820 06/20/2013 AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G CAREFUSION
K131824 06/20/2013 AVAFLEX VERTEBRAL BALLOON SYSTEM CAREFUSION
K121849 06/25/2012 PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE CAREFUSION
K141722 06/25/2014 CAREFUSION GOLD TISSUE MARKER CAREFUSION
K141965 07/21/2014 PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT CAREFUSION
K122422 08/09/2012 PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER CAREFUSION
K112831 09/28/2011 PLEURX PLEURAL CATHETER SYSTEMS CAREFUSION
K103064 10/18/2010 AVAMAX VERTEBRAL BALLOON CAREFUSION
K113854 12/29/2011 PLEURX PERITONEAL CATHETER SYSTEM CAREFUSION
K140831 04/02/2014 MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR CAREFUSION
K143234 11/10/2014 MaxZero Administration Sets CAREFUSION
K132413 08/02/2013 MZ1000 CAREFUSION
K101643 06/10/2010 MODEL LTV 1100 VENTILATOR CAREFUSION
K201155 04/30/2020 PleurX Peritoneal Catheter System CareFusion
K221319 05/06/2022 BD AlarisÖ Pump Epidural Infusion Set CareFusion
K223101 09/30/2022 BD Secondary Infusion Set CareFusion
K221327 05/06/2022 BD AlarisÖ Pump Infusion Sets CareFusion
K093463 11/06/2009 AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 CAREFUSION
K170405 02/10/2017 BD Curve Ascites Shunt CareFusion
K160437 02/17/2016 PleurX Peritoneal Catheter System CareFusion
K171531 05/25/2017 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle CareFusion


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