510(k) Report

Devices descending from K112831

6 later devices reach Pleurx Pleural Catheter Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123033Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…Rocket Medical Plc20132—
+1K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122—
+2K210509Rocket Platinum Cured CathterRocket Medical Plc20210—
+2K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc20170—
+2K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+3K160450Pleurx Pleural Catheter SystemCare Fusion20160—