510(k) Report

Devices descending from K021094

26 later devices reach Introcan Safety IV Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…Becton, Dickinson and Company2020111
+1K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…B.Braun Melsungen AG2011151
+1K030135Safety Introducer NeedleB.Braun Medical, Inc.20037—
+2K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV…Becton Dickinson Infusion Therapy Systems, Inc.20250—
+2K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.201981
+2K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company20174—
+2K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG20179—
+2K113196Vascular SonoPAJUNK GmbH Medizintechnologie20120—
+2K050023Secureloc; AdvancintroducerSpecialized Health Products, Inc.20055—
+3K213085Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.202101
+3K192676Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc.20206—
+3K192493BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20203—
+3K142445Pinpoint GT Safety Introducer NeedleC.R. Bard, Inc.20151—
+3K140513Merit Safety Introducer NeedleMerit Medical Systems, Inc.20140—
+3K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc.20071—
+4K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited20231—
+4K213664B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20223—
+4K201717BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20202—
+4K180725Aspire Introducer NeedleAspire Bariatrics, Inc.20180—
+4K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc.20160—
+5K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC20260—
+5K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…Poly Medicure Limited20260—
+5K220756Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20221—
+5K220584BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.202212
+6K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20250—
+6K241845Introcan Safety® 2 IV CatheterB.Braun Medical, Inc.20240—