510(k) Report

Devices descending from K081288

11 later devices reach Aspira Peritoneal Drainage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110396Aspira Peritoneal Drainage SystemC.R. Bard, Inc.20111017
+2K212675Aspira Peritoneal Drainage SystemMerit Medical Systems, Inc.2021013
+2K160437PleurX Peritoneal Catheter SystemCare Fusion20162—
+2K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion20124—
+2K113854Pleurx Peritoneal Catheter SystemCare Fusion20128—
+3K201155PleurX Peritoneal Catheter SystemCare Fusion20201—
+3K170405BD Curve Ascites ShuntCare Fusion20170—
+3K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122—
+4K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc.20240—
+4K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+5K160450Pleurx Pleural Catheter SystemCare Fusion20160—