510(k) Report

Devices descending from K012562

38 later devices reach Medcomp 14.5F Double Lumen Hemodialysis Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K04099215F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706Medcomp20048—
+1K03050214.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55Medcomp2003132
+1K02175914F X 55CM Ultra-Flow Catheter, Models UFS55, UFT55Medcomp20020—
+1K02031514F X 55CM Ash Split-Cath XL, Model ASPC55-XLMedcomp20020—
+1K020465Medcomp Ash Split-Cath IIMedcomp200229—
+2K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+2K123292T3Medcomp20132—
+2K111651Split Cath IiiMedical Components, Inc.201101
+2K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.200865
+2K072499Novoflo Catheter LTNovosci, Inc.20070—
+2K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc.200773
+2K051280Medcomp Split Cath IIMedcomp20051—
+2K040318Medcomp Split-Cath IIMedcomp20059—
+2K030020Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc.200312—
+2K022678Medcomp SC4Medcomp200311—
+3K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+3K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+3K130889Split Cath RGMedcomp20140—
+3K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20102Class I
+3K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc.20092—
+3K090101Equistream Long-Term Hemodialysis CathetersC.R. Bard, Inc.2009015
+3K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc.20061—
+3K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc.2005813
+3K033294Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…C.R. Bard, Inc.200310—
+4K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+4K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…C. R. Bard20205—
+4K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+4K141363Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterMerit Medical Systems, Inc.20141—
+4K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+4K110936Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.201106
+4K090528Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System…C.R. Bard, Inc.20090—
+4K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc.200702
+5K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.20210—
+5K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.20210—
+5K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc.20202—
+5K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc.20160Class I
+6K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.20201—
+7K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—