510(k) Report

Devices descending from K981994

41 later devices reach Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012562Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc.200238—
+1K011916Super C Hemodialysis/Apheresis Chronic Catheter, Model DC-36 Series, DC-40 Series, DC-45…Horizon Medical Products, Inc.20011—
+2K04099215F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706Medcomp20048—
+2K03050214.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55Medcomp2003132
+2K022905Lifejet F16 Hemodialysis/Apheresis Chronic CatheterHorizon Medical Products, Inc.20020—
+2K02175914F X 55CM Ultra-Flow Catheter, Models UFS55, UFT55Medcomp20020—
+2K02031514F X 55CM Ash Split-Cath XL, Model ASPC55-XLMedcomp20020—
+2K020465Medcomp Ash Split-Cath IIMedcomp200229—
+3K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+3K123292T3Medcomp20132—
+3K111651Split Cath IiiMedical Components, Inc.201101
+3K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.200865
+3K072499Novoflo Catheter LTNovosci, Inc.20070—
+3K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc.200773
+3K051280Medcomp Split Cath IIMedcomp20051—
+3K040318Medcomp Split-Cath IIMedcomp20059—
+3K030020Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc.200312—
+3K022678Medcomp SC4Medcomp200311—
+4K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+4K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+4K130889Split Cath RGMedcomp20140—
+4K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20102Class I
+4K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc.20092—
+4K090101Equistream Long-Term Hemodialysis CathetersC.R. Bard, Inc.2009015
+4K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc.20061—
+4K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc.2005813
+4K033294Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…C.R. Bard, Inc.200310—
+5K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+5K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…C. R. Bard20205—
+5K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+5K141363Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterMerit Medical Systems, Inc.20141—
+5K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+5K110936Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.201106
+5K090528Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System…C.R. Bard, Inc.20090—
+5K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc.200702
+6K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.20210—
+6K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.20210—
+6K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc.20202—
+6K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc.20160Class I
+7K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.20201—
+8K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—