510(k) Report

Devices descending from K053345

43 later devices reach Pro-Line CT Power Injectable CVC, Models CTLINES5S, CTLINE6D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110627Nexsite 9FR Dual Lumen Critical Care Central Venous CatheterMarvao Medical Devices, Ltd.20115—
+1K093309Pro-Line CT (Basic Tray) Model MR28036101Medcomp ( Medical Components)20098—
+1K091953Pro-PiccMedcomp200929—
+1K081904Pro-Picc (Basic Tray, Long Wire Tray, Basic Nursing Tray, Full Nursing Tray)Medcomp2008312
+1K072509Pro-Picc, Basic Tray; Long Wire Tray; Basic Nursing Tray; Full Nursing TrayMedcomp20070—
+1K072391PFM PiccPfm Medical, Inc.20079—
+1K071361R4 Vascular Inc. Pegasus CT Picc, Model 500005-001,002, 004, 005, 500004-001, 002,004,005R4 Vascular, Inc.20070—
+2K180546Jet Power Injectable PICCJet Medical, Inc.20180—
+2K141633Pro-Picc with Valve TechnologyMedical Components, Inc.20140—
+2K141151CT MidlineMedcomp (Medical Components, Inc.)20148—
+2K1316876F X 60CM Triple Pro-Line CT Basic IR SetMedical Components, Inc.20130—
+2K123292T3Medcomp20132—
+2K1236173F Pro-PiccMedical Components, Inc.20131—
+2K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd.20134—
+2K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+2K111651Split Cath IiiMedical Components, Inc.201101
+2K101329Synergy CT PiccHealth Line International Corporation20106—
+2K092347Pro-Picc CTMedcomp20092—
+2K083873Picc (CT Rated and Non-Rated)Pfm Medical, Inc.200983
+3K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+3K171483ArchFlo CT MidlineMedcomp (Dba Medical Components, Inc.)20170—
+3K170770CT MidlineMedical Components, Inc. (dba MedComp)20170—
+3K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+3K153393PowerMidline CatheterC.R. Bard, Inc.201651
+3K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+3K140270Nexus Midline CT CatheterHealth Line International Corporation20141—
+3K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd.20143—
+3K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+3K130034Uni-PiccHealth Line International Corporation20132—
+3K113225Nylus PiccSemprus Biosciences20120—
+3K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+3K113622Orion II CT CVCHealth Line International Corporation (Hlic)20121—
+3K110914Triple Lumen PFM PiccPfm Medical, Inc.20110—
+4K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+4K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+4K200263Health Line CT Midline CatheterHealth Line International Corporation20200—
+4K192533Health Line CT CVCHealth Line International Corporation20190—
+4K181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL…Vygon USA201801
+4K173114primeMidline CathetersPfm Medical, Inc.20181—
+4K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+4K162900PowerMidline CatheterC.R. Bard, Inc.201613
+5K213203Provena (TM) Midline CatheterC.R. Bard, Inc.202201
+5K192802primeMidline CathetersPfm Medical, Inc.20190—