510(k) Report

Devices descending from K021004

21 later devices reach Valved Peelable Introducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030905Medamicus Flowguard Peelable IntroducerMedamicus, Inc.200320—
+2K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc.200419—
+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—
+3K090394Valved Tearway IntroducerMedcomp200912—
+3K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc.20062—
+3K042036Airguard Valved IntroducerC.R. Bard, Inc.20042—
+4K170405BD Curve Ascites ShuntCare Fusion20170—
+4K160437PleurX Peritoneal Catheter SystemCare Fusion20162—
+4K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+4K131148The CVC Wand Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20131—
+4K124046Valved Tearaway Introducer Generation IIMedical Components, Inc.20130—
+4K120617Ptfe Super Sheath IntroducerMartech Medical Products20122—
+4K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+4K072248Viapeel Peelable IntroducerEnpath Medical, Inc.200701
+5K201155PleurX Peritoneal Catheter SystemCare Fusion20201—
+5K182243The CVC WAND Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20180—
+5K160450Pleurx Pleural Catheter SystemCare Fusion20160—
+5K130855Ptfe Super Sheath IntroducerMartech Medical Products20131—
+6K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc.20240—
+6K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.)20160—