510(k) Report

Devices descending from K810460

28 later devices reach Burron Percutaneous Inducer Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021094Introcan Safety IV CatheterB.Braun Medical, Inc.2002261
+1K961745Braun Percutaneous Introducer SetB.Braun Medical, Inc.199601
+2K201075BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter…Becton, Dickinson and Company2020111
+2K111236Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) /…B.Braun Melsungen AG2011151
+2K030135Safety Introducer NeedleB.Braun Medical, Inc.20037—
+3K251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV…Becton Dickinson Infusion Therapy Systems, Inc.20250—
+3K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.201981
+3K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company20174—
+3K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG20179—
+3K113196Vascular SonoPAJUNK GmbH Medizintechnologie20120—
+3K050023Secureloc; AdvancintroducerSpecialized Health Products, Inc.20055—
+4K213085Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.202101
+4K192676Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc.20206—
+4K192493BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20203—
+4K142445Pinpoint GT Safety Introducer NeedleC.R. Bard, Inc.20151—
+4K140513Merit Safety Introducer NeedleMerit Medical Systems, Inc.20140—
+4K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc.20071—
+5K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited20231—
+5K213664B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20223—
+5K201717BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20202—
+5K180725Aspire Introducer NeedleAspire Bariatrics, Inc.20180—
+5K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc.20160—
+6K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC20260—
+6K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…Poly Medicure Limited20260—
+6K220756Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20221—
+6K220584BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.202212
+7K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20250—
+7K241845Introcan Safety® 2 IV CatheterB.Braun Medical, Inc.20240—