510(k) Report

Devices descending from K993191

20 later devices reach TFX Medical Introducer Assembly through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053092Medcomp Vascu-Sheath IIMedcomp200614—
+1K060519Introducer Assembly with Rotator LockTeleflex Medical20061—
+1K022513Medcomp Vascu-Sheath Introducer SetMedcomp200216—
+1K022099Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'SHdc Corp.20020—
+2K1306872F & 3F Vascu-Sheath Tearaway IntroducerMedical Components, Inc.201301
+2K123974Percutaneous Introducer KitTeleflex, Inc.20130—
+2K120617Ptfe Super Sheath IntroducerMartech Medical Products20122—
+2K090394Valved Tearway IntroducerMedcomp200912—
+2K061135Minop Disposable Introducer 10F, Model ME010; 19F, Model ME019Aesculap20060—
+3K130855Ptfe Super Sheath IntroducerMartech Medical Products20131—
+3K124046Valved Tearaway Introducer Generation IIMedical Components, Inc.20130—
+3K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion20124—
+3K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122—
+4K170405BD Curve Ascites ShuntCare Fusion20170—
+4K160437PleurX Peritoneal Catheter SystemCare Fusion20162—
+4K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.)20160—
+4K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+5K201155PleurX Peritoneal Catheter SystemCare Fusion20201—
+5K160450Pleurx Pleural Catheter SystemCare Fusion20160—
+6K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc.20240—