510(k) Report

Devices descending from K994105

20 later devices reach Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd.20134—
+1K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.200865
+1K071202Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc.20071—
+1K072499Novoflo Catheter LTNovosci, Inc.20070—
+1K042016Datascope Proguide Chronic Dialysis CatheterDatascope Corp.20041—
+1K03050214.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55Medcomp2003132
+2K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36…Marvao Medical Devices, Ltd.20161—
+2K140492Nexsite HD (55CM), Hemodialysis Catheter for Long Term UseMarvao Medical Devices, Ltd.20142—
+2K133796Nexsite HD, Hemodialysis Catheter for Long Term Use (32CM), Nexsite HD, Hemodialysis…Marvao Medical Devices, Ltd.20143—
+2K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20102Class I
+2K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc.20092—
+2K091760Dermaport Ported Vascular Access System (Pvas)Dermaport, Inc.20090—
+2K090148Proguide Chronic Dialysis CatheterMerit Medical Systems, Inc.20090Class I
+2K04099215F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706Medcomp20048—
+3K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD…Marvao Medical Devices, Ltd.201801
+3K141363Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterMerit Medical Systems, Inc.20141—
+3K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+3K110936Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.201106
+3K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc.200773
+4K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc.20160Class I