510(k) Report

Devices descending from K010642

15 later devices reach Pleurx Pleural Catheter and Drainage Kits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093307Asept Pleural Drainage SystemPfm Medical, Inc.200942
+1K071095Aspira Pleural Drainage SystemBard Access Systems, Inc.20079—
+2K110409Aspira Pleural Drainage SystemC.R. Bard, Inc.201181
+2K093796Asept Peritoneal Drainage SystemPfm Medical, Inc.201031
+3K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc.20231—
+3K212696Aspira Pleural Drainage SystemMerit Medical Systems, Inc.20230—
+3K160450Pleurx Pleural Catheter SystemCare Fusion20160—
+3K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122—
+3K113354Veta Peritoneal Dialysis CatheterPfm Medical, Inc.201201
+3K112831Pleurx Pleural Catheter SystemsCare Fusion20126—
+4K241278ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc.20250—
+4K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+4K123033Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…Rocket Medical Plc20132—
+5K210509Rocket Platinum Cured CathterRocket Medical Plc20210—
+5K163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitRocket Medical Plc20170—