510(k) Report

Devices descending from K163358

9 later devices reach Introcan Safety 3 Closed IV Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182870Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.201981
+2K213085Introcan Safety 3 Closed IV CatheterB.Braun Medical, Inc.202101
+2K192676Introcan Safety 2 IV Catheter 18-24 gaugeB.Braun Medical, Inc.20206—
+3K231401Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety AdvaPoly Medicure Limited20231—
+3K213664B. Braun Introcan Safety 2 IV CatheterB.Braun Medical, Inc.20223—
+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—
+5K241845Introcan Safety® 2 IV CatheterB.Braun Medical, Inc.20240—