510(k) Report

Devices descending from K110443

21 later devices reach BD Insyte Autoguard BC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230616Polyguard and Polyshield Safety IV CathetersPoly Medicure Limited20231—
+1K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…Becton, Dickinson and Company2020111
+1K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company20174—
+1K140504Accucath BC Intravascular Catheter SystemVascular Pathways, Inc.20147—
+1K130518Mini-Midline Extended Dwell Safety CatheterLuther Needlesafe Products, Inc.20130—
+1K123267Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp.20120—
+1K113700Viavalve Safety IV CatheterSmiths Medical Asd, Inc.20121—
+2K252677Polyshield Safety IV CathetersPoly Medicure Limited20250—
+2K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV…Becton Dickinson Infusion Therapy Systems, Inc.20250—
+2K192493BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20203—
+2K160235ViaValve Safety I.V. CatheterSmiths Medical Asd, Inc.201601
+2K153298AccuCath Intravascular CatheterC.R. Bard, Inc.20155—
+2K142136Accucath Midline Catheter SystemVascular Pathways, Inc.20150—
+3K201717BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20202—
+3K162894AccuCath Intravascular CatheterC.R. Bard, Inc.20164—
+4K243105Ruby Intravascular CatheterVenocare, Inc.20251—
+4K233106AccuCath Ace™ Intravascular CatheterBard Access Systems, Inc. (C.R. Bard, Inc.)20240—
+4K220584BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.202212
+4K191232AccuCath Ace Intravascular CatheterC.R. Bard, Inc.20190—
+5K260432Ruby Intravascular CatheterVenocare, Inc.20260—
+5K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20250—