510(k) Report

Devices descending from K040150

19 later devices reach Modification to Medamicus Flowguard Peelable Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+1K090394Valved Tearway IntroducerMedcomp200912—
+1K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc.20062—
+1K042036Airguard Valved IntroducerC.R. Bard, Inc.20042—
+2K170405BD Curve Ascites ShuntCare Fusion20170—
+2K160437PleurX Peritoneal Catheter SystemCare Fusion20162—
+2K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+2K131148The CVC Wand Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20131—
+2K124046Valved Tearaway Introducer Generation IIMedical Components, Inc.20130—
+2K120617Ptfe Super Sheath IntroducerMartech Medical Products20122—
+2K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+2K072248Viapeel Peelable IntroducerEnpath Medical, Inc.200701
+3K201155PleurX Peritoneal Catheter SystemCare Fusion20201—
+3K182243The CVC WAND Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20180—
+3K160450Pleurx Pleural Catheter SystemCare Fusion20160—
+3K130855Ptfe Super Sheath IntroducerMartech Medical Products20131—
+4K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc.20240—
+4K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.)20160—