510(k) Report

Devices descending from K992198

136 later devices reach Urethane Picc Line Model Upics- through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Arrow International, Inc. (Subsidiary of Teleflex, Inc.)201612
+6K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+6K160747Angel CatheterBio2 Medical, Inc.20160—
+6K153393PowerMidline CatheterC.R. Bard, Inc.201651
+6K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20160—
+6K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+6K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+6K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+6K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+6K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+6K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd.20143—
+6K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+6K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+6K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+6K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+6K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+6K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+6K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC20120—
+7K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+7K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+7K210629SecurAcathInterrad Medical, Inc.20210—
+7K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+7K173114primeMidline CathetersPfm Medical, Inc.20181—
+7K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+7K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+7K162900PowerMidline CatheterC.R. Bard, Inc.201613
+7K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+7K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+7K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+7K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+7K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+8K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+8K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+8K192802primeMidline CathetersPfm Medical, Inc.20190—
+8K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+8K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I