510(k) Report

Devices descending from K053501

108 later devices reach Powerpicc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.20161—
+1K102159Powerpicc SV CathetersC.R. Bard, Inc.201053
+1K093406Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc.2010038
+1K0939276F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central…C.R. Bard, Inc.20106—
+1K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc.200912—
+1K082047Securacath Catheter, Model SPK01Interrad Medical, Inc.20086—
+1K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp2008312
+1K080604Pressure Injfectable PiccArrow International, Inc.2008181
+1K072509Pro-Picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing TrayMedcomp20070—
+1K072230Powerpicc SoloC.R. Bard, Inc.200754
+1K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.200766—
+1K063848Powergroshong Picc CatheterC.R. Bard, Inc.20076—
+2K210264BD PowerPiCC CatheterBard Access Systems, Inc.20210Class I
+2K1819045 FR Dual Lumen Piper PICCPiper Access, LLC20180—
+2K162443PowerPICC Provena CathetersC.R. Bard, Inc.201621
+2K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)20150Class I
+2K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+2K141633Pro-Picc with Valve TechnologyMedical Components, Inc.20140—
+2K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc.20142Class I
+2K130897Medcomp Vascu-Picc with ValveMedcomp ( Medical Components)20130—
+2K123292T3Medcomp20132—
+2K1236173F Pro-PiccMedical Components, Inc.20131—
+2K121941Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)2012010
+2K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc.20122Class I
+2K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca20107Class I
+2K101326NMI ICNavilyst Medical, Inc.201026—
+2K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Arrow Intl., Inc.201014—
+2K092306Securacath UniversalInterrad Medical, Inc.20104—
+2K091953Pro-PiccMedcomp200929—
+2K092347Pro-Picc CTMedcomp20092—
+2K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc.20095—
+3K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation20230—
+3K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC202006
+3K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+3K180546Jet Power Injectable PICCJet Medical, Inc.20180—
+3K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F…C.R. Bard, Inc (Bard Has Joined Bd)201801
+3K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.20171—
+3K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc.20151Class I
+3K141151CT MidlineMedcomp (Medical Components, Inc.)20148—
+3K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc.20140—
+3K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc.20130—
+3K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+3K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+3K111939M/29TM - Pressure InjectableFlexicath, Ltd.20120—
+3K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.)201212Class I
+3K120935SecuracathInterrad Medical, Inc.20123—
+3K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien201212
+3K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+3K111651Split Cath IiiMedical Components, Inc.201101
+3K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+3K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components)20098—
+4K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+4K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation20200—
+4K180769SecurAcathInterrad Medical, Inc.20182—
+4K172885HydroPICCAccess Vascular, Inc.20185—
+4K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)20170—
+4K170770CT MidlineMedical Components, Inc. (dba MedComp)20170—
+4K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Arrow International, Inc. (Subsidiary of Teleflex, Inc.)201612
+4K153393PowerMidline CatheterC.R. Bard, Inc.201651
+4K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20160—
+4K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+4K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+4K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+4K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+4K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.20137—
+4K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.2013312
+4K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+4K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.)20124—
+4K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+4K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+4K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+4K101329Synergy CT PiccHealth Line International Corporation20106—
+5K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+5K213855Arrow Pressure Injectable Midline CatheterArrow International, LLC Subsidiary of Teleflex Incorporated20220Class I
+5K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+5K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+5K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…Interrad Medical, Inc.20191—
+5K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+5K173114primeMidline CathetersPfm Medical, Inc.20181—
+5K162900PowerMidline CatheterC.R. Bard, Inc.201613
+5K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+5K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+5K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+5K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+5K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+5K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+5K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+5K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+5K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+5K130034Uni-PiccHealth Line International Corporation20132—
+5K113225Nylus PiccSemprus Biosciences20120—
+5K113622Orion II CT CVCHealth Line International Corporation (Hlic)20121—
+6K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+6K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+6K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+6K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+6K210629SecurAcathInterrad Medical, Inc.20210—
+6K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+6K192533Health Line CT CVCHealth Line International Corporation20190—
+6K192802primeMidline CathetersPfm Medical, Inc.20190—