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
+1K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc.200714Class I
+1K992198Urethane Picc Line Model Upics-Cook, Inc.1999136—
+1K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc.199713Class I
+2K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd)20193—
+2K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC20161—
+2K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+2K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.)20124—
+2K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC20092—
+2K041849Turbo-Flo PiccCook, Inc.20058—
+2K014241Coolgard 3000, Cooline, Start-UP, Models 3000, CL-2085B, CL-2295A, CG-500DAlsius Corp.2003116
+2K021557Spectrum Silicone CatheterCook, Inc.2003126—
+2K013182Triple Lumen Central Venous CatheterCook, Inc.20020—
+3K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemBecton Dickinson Inc. (Bd)20250—
+3K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products20230—
+3K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)Bard Access Systems, Inc. (Bard Has Joined Bd)20200—
+3K171994Silicone Peripherally Inserted Central Venous Catheter Set/TrayCook Incorporated20180—
+3K172885HydroPICCAccess Vascular, Inc.20185—
+3K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC201801
+3K161496Turbo-Flo PICC SetsCook Incorporated20160—
+3K160747Angel CatheterBio2 Medical, Inc.20160—
+3K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.201634
+3K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…Zoll Circulation, Inc.2015421
+3K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+3K113565Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central…Edwards Lifesciences, LLC20120—
+3K101987Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…Zoll Circulation20106—
+3K082047Securacath Catheter, Model SPK01Interrad Medical, Inc.20086—
+3K081690Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterCook, Inc.20084—
+3K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005119—
+3K051912Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…Alsius Corp.20050—
+3K033623Celsius Control SystemInnercool Therapies, Inc.20042—
+4K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20212—
+4K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+4K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+4K141139Solex Intravascular Heat Exchange CatheterZoll Circulation20144—
+4K133634Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter SetCook, Inc.20130—
+4K102159Powerpicc SV CathetersC.R. Bard, Inc.201053
+4K101326NMI ICNavilyst Medical, Inc.201026—
+4K092306Securacath UniversalInterrad Medical, Inc.20104—
+4K100974Spectrum Turbo-Ject Picc SetCook Incorporated20102—
+4K0939276F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central…C.R. Bard, Inc.20106—
+4K091586Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp20099—
+4K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc.200912—
+4K083081Modification to Securacath, Model: SPK01Interrad Medical, Inc.20095—
+4K080908Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation200811
+4K080604Pressure Injfectable PiccArrow International, Inc.2008181
+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—
+4K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.200647—
+5K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+5K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+5K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20230—
+5K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…Zoll Circulation, Inc.20221—
+5K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+5K210264BD PowerPiCC CatheterBard Access Systems, Inc.20210Class I
+5K162443PowerPICC Provena CathetersC.R. Bard, Inc.201621
+5K152946TempedySeiratherm GmbH20160—
+5K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+5K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.20161—
+5K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)20150Class I
+5K141633Pro-Picc with Valve TechnologyMedical Components, Inc.20140—
+5K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc.20142Class I
+5K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+5K130897Medcomp Vascu-Picc with ValveMedcomp ( Medical Components)20130—
+5K123292T3Medcomp20132—
+5K1236173F Pro-PiccMedical Components, Inc.20131—
+5K130034Uni-PiccHealth Line International Corporation20132—
+5K122423Vasu-PiccMedical Components, Inc.20120—
+5K121941Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)2012010
+5K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+5K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+5K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc.20122Class I
+5K120935SecuracathInterrad Medical, Inc.20123—
+5K110627Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd.20115—
+5K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+5K111244Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Cook, Inc.20111—
+5K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca20107Class I
+5K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Arrow Intl., Inc.201014—
+5K101329Synergy CT PiccHealth Line International Corporation20106—
+5K091953Pro-PiccMedcomp200929—
+5K071875V-Cath Poly PiccHdc Corp.20079—
+6K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—
+6K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation20230—
+6K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+6K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC202006
+6K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+6K180546Jet Power Injectable PICCJet Medical, Inc.20180—
+6K1819045 FR Dual Lumen Piper PICCPiper Access, LLC20180—
+6K180769SecurAcathInterrad Medical, Inc.20182—
+6K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F…C.R. Bard, Inc (Bard Has Joined Bd)201801
+6K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.20171—
+6K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+6K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc.20151Class I
+6K141818Turbo-Ject Picc SetsCook Corporated20140—
+6K141151CT MidlineMedcomp (Medical Components, Inc.)20148—
+6K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc.20140—
+6K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+6K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc.20130—
+6K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+6K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.20137—