510(k) Report

Devices descending from K070996

66 later devices reach 4 FR Single Lumen (SL) Powerpicc Catheter 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
+1K101326NMI ICNavilyst Medical, Inc.201026—
+1K091953Pro-PiccMedcomp200929—
+1K072230Powerpicc SoloC.R. Bard, Inc.200754
+2K210264BD PowerPiCC CatheterBard Access Systems, Inc.20210Class I
+2K180546Jet Power Injectable PICCJet Medical, Inc.20180—
+2K1819045 FR Dual Lumen Piper PICCPiper Access, LLC20180—
+2K162443PowerPICC Provena CathetersC.R. Bard, Inc.201621
+2K141633Pro-Picc with Valve TechnologyMedical Components, Inc.20140—
+2K141151CT MidlineMedcomp (Medical Components, Inc.)20148—
+2K130897Medcomp Vascu-Picc with ValveMedcomp ( Medical Components)20130—
+2K123292T3Medcomp20132—
+2K1236173F Pro-PiccMedical Components, Inc.20131—
+2K121089Nmi Picc IiiNavilyst Medical, Inc.201223—
+2K121990Picc Convenience KitNavilyst Medical, Inc.2012017
+2K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+2K111651Split Cath IiiMedical Components, Inc.201101
+2K111906Xcela Hybrid Picc with Pasv Valve TechnologyNavilyst Medical, Inc.201114—
+2K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components)20098—
+3K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+3K1805483F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F…C.R. Bard, Inc (Bard Has Joined Bd)201801
+3K172885HydroPICCAccess Vascular, Inc.20185—
+3K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)20170—
+3K170770CT MidlineMedical Components, Inc. (dba MedComp)20170—
+3K162441PowerPICC Provena Catheters with SOLO Valve TechnologyC.R. Bard, Inc.20171—
+3K153393PowerMidline CatheterC.R. Bard, Inc.201651
+3K152409Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICCNavilyst Medical, Inc.201506
+3K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+3K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+3K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc.20130—
+3K131694Nmi Port II CatheterNavilyst Medical, Inc.201322
+3K131942Nmi Picc Iii Catheter, Nmi Hpicc Iii CatheterNavilyst Medical, Inc.20137—
+3K131038Nmi Picc Maximal Barrier Nursing KitsNavilyst Medical, Inc.2013312
+3K122882Nmi Hpicc IiiNavilyst Medical, Inc.201212—
+3K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+3K101329Synergy CT PiccHealth Line International Corporation20106—
+4K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+4K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+4K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc.20200—
+4K193015HydroPICC (PICC-142)Access Vascular, Inc.202044
+4K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+4K173114primeMidline CathetersPfm Medical, Inc.20181—
+4K162900PowerMidline CatheterC.R. Bard, Inc.201613
+4K153228NMI Port, NMI Port IINavilyst Medical, Inc.20150—
+4K150448NMI PICC III and NMI PICC IVNavilyst Medical, Inc.2015020
+4K142616PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.2014213
+4K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+4K140266Nmi Picc IVNavilyst Medical, Inc.20143—
+4K133264Nmi Picc IiiNavilyst Medical, Inc.20136—
+4K130034Uni-PiccHealth Line International Corporation20132—
+4K113225Nylus PiccSemprus Biosciences20120—
+4K113622Orion II CT CVCHealth Line International Corporation (Hlic)20121—
+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—
+5K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+5K213550HydroPICC 5F Dual Lumen CatheterAccess Vascular, Inc.202222
+5K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+5K192533Health Line CT CVCHealth Line International Corporation20190—
+5K192802primeMidline CathetersPfm Medical, Inc.20190—
+5K163452PICC Maximal Barrier Nursing KitNavilyst Medical, Inc.201715
+5K153469Cathtong I PICC CatheterL&Z Us, Inc.20160—
+5K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+5K150527Xcela Power Injectable PICCNavilyst Medical, Inc.20151—
+6K252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…Spectrum Vascular20250—
+6K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…Access Vascular, Inc.20250—