510(k) Report

Devices descending from K030905

20 later devices reach Medamicus Flowguard Peelable Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc.200419—
+2K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion20124—
+2K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122—
+2K090394Valved Tearway IntroducerMedcomp200912—
+2K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc.20062—
+2K042036Airguard Valved IntroducerC.R. Bard, Inc.20042—
+3K170405BD Curve Ascites ShuntCare Fusion20170—
+3K160437PleurX Peritoneal Catheter SystemCare Fusion20162—
+3K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+3K131148The CVC Wand Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20131—
+3K124046Valved Tearaway Introducer Generation IIMedical Components, Inc.20130—
+3K120617Ptfe Super Sheath IntroducerMartech Medical Products20122—
+3K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+3K072248Viapeel Peelable IntroducerEnpath Medical, Inc.200701
+4K201155PleurX Peritoneal Catheter SystemCare Fusion20201—
+4K182243The CVC WAND Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20180—
+4K160450Pleurx Pleural Catheter SystemCare Fusion20160—
+4K130855Ptfe Super Sheath IntroducerMartech Medical Products20131—
+5K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc.20240—
+5K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.)20160—