510(k) Report

Devices descending from K010306

13 later devices reach Medcomp Excell Split Tip Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113487Hemo-Cath 10F, Hemo-Cath 12.5FMedical Components, Inc.20123—
+1K04099215F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706Medcomp20048—
+2K130851Cascade Hemodialysis/Apheresis CatheterHealth Line International Corporation20141—
+2K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc.20120—
+2K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc.200773
+3K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—
+3K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc.20092—
+3K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.200865
+4K141363Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterMerit Medical Systems, Inc.20141—
+4K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20102Class I
+5K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc.20160Class I
+5K131260Nmi Dialysis CatheterNavilyst Medical, Inc.20140Class I
+5K110936Duraflow 2 Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.201106