510(k) Report

Devices descending from K122422

4 later devices reach Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170405BD Curve Ascites ShuntCare Fusion20170—
+1K160437PleurX Peritoneal Catheter SystemCare Fusion20162—
+2K201155PleurX Peritoneal Catheter SystemCare Fusion20201—
+3K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc.20240—