FDA 510(k) Applications for Medical Device Product Code "NZW"
(Heparin, Vascular Access Flush)

FDA 510(k) Number Applicant Device Name Decision Date
K092938 APP PHARMACEUTICALS, LLC HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710 06/18/2010
K090680 BECTON DICKINSON & CO. HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE 06/10/2009
K163591 Becton Dickinson and Company BD PosiFlush Heparin Lock Flush Syringe 02/27/2017
K061497 EXCELSIOR MEDICAL CORP. SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML 02/23/2007
K023740 EXCELSIOR MEDICAL CORP. SYREX PRE-FILLED SYRINGE 05/13/2003
K133446 Excelsior Medical Corporation HEPARIN LOCK / FLUSH SYRINGES 11/14/2014
K092491 MEDEFIL, INC. MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES 02/03/2010


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