510(k) Report

Devices descending from K000824

26 later devices reach Percutaneous Introducer, Model 10383-XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081394Ptfe Interlock Peelable IntroducersEnpath Medical, Inc.20083—
+1K021004Valved Peelable IntroducerMedamicus, Inc.200221—
+2K093023Ptfe Peelable IntroducerGreat Batch Medical20092—
+2K030905Medamicus Flowguard Peelable IntroducerMedamicus, Inc.200320—
+3K102540Ptfe Portable IntroducerGreat Batch Medical20101—
+3K040150Modification to Medamicus Flowguard Peelable IntroducerMedamicus, Inc.200419—
+4K123974Percutaneous Introducer KitTeleflex, Inc.20130—
+4K122422Pleurx Pleural Catheter System Pleurx Catheter Access Kit Pleurx Slide Valved Peelable…Care Fusion20124—
+4K121849Pleurx Pleural Catheter System, Pleurx Catheter Access Kit, Pleurx Catheter Insertion…Care Fusion20122—
+4K090394Valved Tearway IntroducerMedcomp200912—
+4K063182Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXXEnpath Medical, Inc.20062—
+4K042036Airguard Valved IntroducerC.R. Bard, Inc.20042—
+5K170405BD Curve Ascites ShuntCare Fusion20170—
+5K160437PleurX Peritoneal Catheter SystemCare Fusion20162—
+5K141965Pleurx Pleural Catheter System, Pleurx Catheter Access KitCare Fusion20151—
+5K131148The CVC Wand Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20131—
+5K124046Valved Tearaway Introducer Generation IIMedical Components, Inc.20130—
+5K120617Ptfe Super Sheath IntroducerMartech Medical Products20122—
+5K093232Optiseal Enpath Valved Ptfe Peelable IntroducerGreat Batch Medical201001
+5K072248Viapeel Peelable IntroducerEnpath Medical, Inc.200701
+6K201155PleurX Peritoneal Catheter SystemCare Fusion20201—
+6K182243The CVC WAND Safety Introducer with Valved Peelable SheathAccess Scientific, LLC20180—
+6K160450Pleurx Pleural Catheter SystemCare Fusion20160—
+6K130855Ptfe Super Sheath IntroducerMartech Medical Products20131—
+7K241946PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal…Bard Peripheral Vascular, Inc.20240—
+7K153246PTFE Super Sheath Introducer 2.1Medcomp (Medical Components, Inc.)20160—