510(k) Report

Devices descending from K864038

31 later devices reach Supercath I.V. Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050114Supercath Z3VTogo Medikit Co., Ltd.200530—
+2K112290Supercath Z3VTogo Medikit Co., Ltd.20124—
+2K081953Supercath 5Togo Medikit Co., Ltd.200928—
+2K052267Supercath VTogo Medikit Co., Ltd.20060—
+3K140419SUPERCATH5Togo Medikit Co., Ltd.20143—
+3K093546Supercath 5 Model SP120-XX-XX, SP125-XX-XXTogo Medikit Co., Ltd.200927—
+4K190001Supercath 5Togo Medikit Co., Ltd.20190—
+4K172496Supercath 5 (26G)Togo Medikit Co., Ltd.20181—
+4K160592Supercath 6Togo Medikit Co., Ltd.20160—
+4K110443BD Insyte Autoguard BCBecton, Dickinson & CO201121—
+5K230616Polyguard and Polyshield Safety IV CathetersPoly Medicure Limited20231—
+5K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…Becton, Dickinson and Company2020111
+5K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company20174—
+5K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc.20147—
+5K130518Mini-Midline Extended Dwell Safety CatheterLuther Needlesafe Products, Inc.20130—
+5K123267Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp.20120—
+5K113700Viavalve Safety IV CatheterSmiths Medical Asd, Inc.20121—
+6K252677Polyshield Safety IV CathetersPoly Medicure Limited20250—
+6K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV…Becton Dickinson Infusion Therapy Systems, Inc.20250—
+6K192493BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20203—
+6K160235ViaValve Safety I.V. CatheterSmiths Medical Asd, Inc.201601
+6K153298AccuCath Intravascular CatheterC.R. Bard, Inc.20155—
+6K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+7K201717BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20202—
+7K162894AccuCath Intravascular CatheterC.R. Bard, Inc.20164—
+8K243105Ruby Intravascular CatheterVenocare, Inc.20251—
+8K233106AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.)20240—
+8K220584BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.202212
+8K191232AccuCath Ace Intravascular CatheterC.R. Bard, Inc.20190—
+9K260432Ruby Intravascular CatheterVenocare, Inc.20260—
+9K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20250—