FDA 510(k) Applications Submitted by Joy Greidanus

FDA 510(k) Number Submission Date Device Name Applicant
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


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