510(k) Report

Devices descending from K111236

15 later devices reach Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.201981
+1K172506BD Cathena Safety IV CatheterBecton, Dickinson and Company20174—
+1K163358Introcan Safety 3 Closed IV CatheterB.Braun Melsungen AG20179—
+2K213085Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.202101
+2K192676Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc.20206—
+2K192493BD Cathena (TM) Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20203—
+3K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited20231—
+3K213664B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20223—
+3K201717BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20202—
+4K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC20260—
+4K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…Poly Medicure Limited20260—
+4K220756Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20221—
+4K220584BD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.202212
+5K251155BD Cathena™ Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20250—
+5K241845Introcan Safety® 2 IV CatheterB.Braun Medical, Inc.20240—