510(k) Report

Devices descending from K090394

12 later devices reach Valved Tearway Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K124046Valved Tearaway Introducer Generation IIMedical Components, Inc.20130—
+1K120617Ptfe Super Sheath IntroducerMartech Medical Products20122—
+1K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion20124—
+1K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122—
+2K170405BD Curve Ascites ShuntCare Fusion20170—
+2K160437PleurX Peritoneal Catheter SystemCare Fusion20162—
+2K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+2K130855Ptfe Super Sheath IntroducerMartech Medical Products20131—
+3K201155PleurX Peritoneal Catheter SystemCare Fusion20201—
+3K160450Pleurx Pleural Catheter SystemCare Fusion20160—
+3K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.)20160—
+4K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc.20240—