510(k) Report

Devices descending from K100775

3 later devices reach BD Intima II Closed IV Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143610BD Intima II Closed IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.20152—
+2K200891BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter SystemBecton, Dickinson and Company20210—
+2K172204BD Intima II PLUS Closed IV Catheter SystemBecton, Dickinson and Company20171—