510(k) Report

Devices descending from K862056

151 later devices reach [Central Venous][Multi-Lumen] Catheter W/Flex Tip through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.2013312
+6K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd.20134—
+6K113225Nylus PiccSemprus Biosciences20120—
+6K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+6K111939M/29TM - Pressure InjectableFlexicath, Ltd.20120—
+6K113622Orion II CT CVCHealth Line International Corporation (Hlic)20121—
+6K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.)201212Class I
+6K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien201212
+6K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+6K111651Split Cath IiiMedical Components, Inc.201101
+6K110914Triple Lumen PFM PiccPfm Medical, Inc.20110—
+6K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components)20098—
+6K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.200983
+7K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+7K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation20200—
+7K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+7K192533Health Line CT CVCHealth Line International Corporation20190—
+7K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…Interrad Medical, Inc.20191—
+7K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)20170—
+7K170770CT MidlineMedical Components, Inc. (dba MedComp)20170—
+7K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Arrow International, Inc. (Subsidiary of Teleflex, Inc.)201612
+7K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+7K153393PowerMidline CatheterC.R. Bard, Inc.201651
+7K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20160—
+7K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+7K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+7K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+7K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+7K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+7K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd.20143—
+7K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+7K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+7K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+7K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+7K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+8K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+8K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+8K210629SecurAcathInterrad Medical, Inc.20210—
+8K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+8K173114primeMidline CathetersPfm Medical, Inc.20181—
+8K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+8K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+8K162900PowerMidline CatheterC.R. Bard, Inc.201613
+8K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+8K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+8K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+8K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+9K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+9K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+9K192802primeMidline CathetersPfm Medical, Inc.20190—
+9K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I