510(k) Report

Devices descending from K001901

250 later devices reach Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141026LeaderflexVygon20141—
+1K091586Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp20099—
+1K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen…C.R. Bard, Inc.2001247—
+2K212370Leaderflex Mini and Leaderflex NanoVygon USA20220—
+2K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+2K123292T3Medcomp20132—
+2K1236173F Pro-PiccMedical Components, Inc.20131—
+2K130034Uni-PiccHealth Line International Corporation20132—
+2K122423Vasu-PiccMedical Components, Inc.20120—
+2K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003246—
+3K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+3K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+3K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc.20130—
+3K101189Reavillmed Pressure Monitoring System and PiccReavillmed20100—
+3K033389Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc.20042081
+3K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20042391
+4K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+4K102159Powerpicc SV CathetersC.R. Bard, Inc.201053
+4K071875V-Cath Poly PiccHdc Corp.20079—
+4K072230Powerpicc SoloC.R. Bard, Inc.200754
+4K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.200766—
+4K062579Omnipicc P.I.Rita Medical Systems, Inc.200610—
+4K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc.200643—
+4K053345Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6DMedcomp2006431
+4K051102Omnipicc PIRita Medical Systems, Inc.200511—
+4K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005119—
+4K041849Turbo-Flo PiccCook, Inc.20058—
+4K0514176 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc.20051261
+4K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005199—
+4K050185Powerhohn and Powerline CathetersC.R. Bard, Inc.2005127—
+4K0435026 FR Poly Per-Q-Cath Triple Lumen PiccC.R. Bard, Inc.2005133—
+5K210264BD PowerPiCC CatheterBard Access Systems, Inc.20210Class I
+5K162443PowerPICC Provena CathetersC.R. Bard, Inc.201621
+5K161496Turbo-Flo PICC SetsCook Incorporated20160—
+5K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.20161—
+5K141633Pro-Picc with Valve TechnologyMedical Components, Inc.20140—
+5K130897Medcomp Vascu-Picc with ValveMedcomp ( Medical Components)20130—
+5K110914Triple Lumen PFM PiccPfm Medical, Inc.20110—
+5K110627Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd.20115—
+5K101326NMI ICNavilyst Medical, Inc.201026—
+5K101329Synergy CT PiccHealth Line International Corporation20106—
+5K0939276F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central…C.R. Bard, Inc.20106—
+5K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components)20098—
+5K091953Pro-PiccMedcomp200929—
+5K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc.200912—
+5K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.200983
+5K082047Securacath Catheter, Model SPK01Interrad Medical, Inc.20086—
+5K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp2008312
+5K080604Pressure Injfectable PiccArrow International, Inc.2008181
+5K072509Pro-Picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing TrayMedcomp20070—
+5K072391PFM PiccPfm Medical, Inc.20079—
+5K071361R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005R4 Vascular, Inc.20070—
+5K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc.20064218
+5K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.200647—
+5K053501PowerpiccBard Access Systems, Inc.2006108—
+5K051672PowerpiccBard Access Systems, Inc.20051781
+6K180546Jet Power Injectable PICCJet Medical, Inc.20180—
+6K1819045 FR Dual Lumen Piper PICCPiper Access, LLC20180—
+6K173956Biowy PlCC CatheterBiowy Corporation20181—
+6K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F…C.R. Bard, Inc (Bard Has Joined Bd)201801
+6K172899Vygon PICCsVygon USA20182—
+6K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.20171—
+6K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)20150Class I
+6K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+6K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc.20142Class I
+6K141151CT MidlineMedcomp (Medical Components, Inc.)20148—
+6K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd.20134—
+6K113225Nylus PiccSemprus Biosciences20120—
+6K121941Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)2012010
+6K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+6K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+6K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc.20122Class I
+6K113622Orion II CT CVCHealth Line International Corporation (Hlic)20121—
+6K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+6K111651Split Cath IiiMedical Components, Inc.201101
+6K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+6K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca20107Class I
+6K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Arrow Intl., Inc.201014—
+6K092306Securacath UniversalInterrad Medical, Inc.20104—
+6K093406Morpheus Smart Picc CT and Procedure Kit Model 12105509, 12105519AngioDynamics, Inc.2010038
+6K092347Pro-Picc CTMedcomp20092—
+6K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20093811
+6K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc.20095—
+6K081626Flowpicc ConsoleVasonova, Inc.200839—
+6K081625Flowpicc StyletVasonova, Inc.200840—
+6K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc.200714Class I
+6K063848Powergroshong Picc CatheterC.R. Bard, Inc.20076—
+6K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.2006661
+7K252355K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure TubingSb-Kawasumi Laboratories, Inc.20250—
+7K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation20230—
+7K192246Biowy PICC Catheter S KitBiowy Corporation20200—
+7K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC202006
+7K191195PiccGuardPiccguard, LLC20201—
+7K192533Health Line CT CVCHealth Line International Corporation20190—
+7K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd)20193—
+7K181446Bard Power-Injectable Implantable Ports (PowerPorts®)C.R. Bard, Inc.20190—
+7K172885HydroPICCAccess Vascular, Inc.20185—
+7K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)20170—
+7K172397Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20170—
+7K170770CT MidlineMedical Components, Inc. (dba MedComp)20170—