510(k) Report

Devices descending from K021557

126 later devices reach Spectrum Silicone Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171994Silicone Peripherally Inserted Central Venous Catheter Set/TrayCook Incorporated20180—
+1K172885HydroPICCAccess Vascular, Inc.20185—
+1K081690Spectrum Turbo-Ject Peripherally Inserted Central Venous CatheterCook, Inc.20084—
+1K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc.2005119—
+2K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+2K133634Spectrum Turbo-Ject Peripherally Inserted Central Venous Catheter SetCook, Inc.20130—
+2K102159Powerpicc SV CathetersC.R. Bard, Inc.201053
+2K101326NMI ICNavilyst Medical, Inc.201026—
+2K100974Spectrum Turbo-Ject Picc SetCook Incorporated20102—
+2K0939276F Triple Lumen Powerline Central Venous Catheter, 5F Dual Lumen Powerline Central…C.R. Bard, Inc.20106—
+2K091586Vascu-Picc and Midline Catheters, Single, Double and Triple LumenMedcomp20099—
+2K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc.200912—
+2K080604Pressure Injfectable PiccArrow International, Inc.2008181
+2K072230Powerpicc SoloC.R. Bard, Inc.200754
+2K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc.200766—
+2K062579Omnipicc P.I.Rita Medical Systems, Inc.200610—
+2K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc.200647—
+3K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…Access Vascular, Inc.20250—
+3K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…Access Vascular, Inc.20250—
+3K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+3K210264BD PowerPiCC CatheterBard Access Systems, Inc.20210Class I
+3K162443PowerPICC Provena CathetersC.R. Bard, Inc.201621
+3K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.20161—
+3K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)20150Class I
+3K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+3K141633Pro-Picc with Valve TechnologyMedical Components, Inc.20140—
+3K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc.20142Class I
+3K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+3K130897Medcomp Vascu-Picc with ValveMedcomp ( Medical Components)20130—
+3K123292T3Medcomp20132—
+3K1236173F Pro-PiccMedical Components, Inc.20131—
+3K130034Uni-PiccHealth Line International Corporation20132—
+3K122423Vasu-PiccMedical Components, Inc.20120—
+3K121941Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)2012010
+3K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+3K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+3K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc.20122Class I
+3K110627Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd.20115—
+3K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+3K111244Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)Cook, Inc.20111—
+3K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca20107Class I
+3K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model…Arrow Intl., Inc.201014—
+3K101329Synergy CT PiccHealth Line International Corporation20106—
+3K091953Pro-PiccMedcomp200929—
+3K071875V-Cath Poly PiccHdc Corp.20079—
+3K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc.200714Class I
+4K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—
+4K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation20230—
+4K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+4K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC202006
+4K190855BD Acute Central LineBard Access Systems, Inc. (Bard Has Joined Bd)20193—
+4K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+4K180546Jet Power Injectable PICCJet Medical, Inc.20180—
+4K1819045 FR Dual Lumen Piper PICCPiper Access, LLC20180—
+4K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F…C.R. Bard, Inc (Bard Has Joined Bd)201801
+4K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.20171—
+4K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC20161—
+4K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+4K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc.20151Class I
+4K141818Turbo-Ject Picc SetsCook Corporated20140—
+4K141151CT MidlineMedcomp (Medical Components, Inc.)20148—
+4K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc.20140—
+4K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+4K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc.20130—
+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
+4K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd.20134—
+4K121501Arrow Jugular Axillo-Subclavian Central Catheter (Jacc)Arrow International (Subsidiary of Teleflex Inc.)20124—
+4K113225Nylus PiccSemprus Biosciences20120—
+4K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+4K111939M/29TM - Pressure InjectableFlexicath, Ltd.20120—
+4K113622Orion II CT CVCHealth Line International Corporation (Hlic)20121—
+4K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.)201212Class I
+4K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien201212
+4K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+4K111651Split Cath IiiMedical Components, Inc.201101
+4K110914Triple Lumen PFM PiccPfm Medical, Inc.20110—
+4K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components)20098—
+4K091709Multi-Med Central Venous Catheters, Models: M3720HKIC, M4820HKICEdwards Lifesciences, LLC20092—
+4K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.200983
+5K242429CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion SystemBecton Dickinson Inc. (Bd)20250—
+5K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+5K221827Mais Central Venous CatheterSaudi Mais Co. For Medical Products20230—
+5K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation20200—
+5K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+5K200266BD Centro Vena Acute Central Line (7 French Dual Lumen)Bard Access Systems, Inc. (Bard Has Joined Bd)20200—
+5K192533Health Line CT CVCHealth Line International Corporation20190—
+5K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…Edwards Lifescience, LLC201801
+5K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)20170—
+5K170770CT MidlineMedical Components, Inc. (dba MedComp)20170—
+5K161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and…Arrow International, Inc. (Subsidiary of Teleflex, Inc.)201612
+5K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+5K160747Angel CatheterBio2 Medical, Inc.20160—
+5K153393PowerMidline CatheterC.R. Bard, Inc.201651
+5K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20160—
+5K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+5K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+5K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+5K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213