510(k) Report

Devices descending from K020465

29 later devices reach Medcomp Ash Split-Cath II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123292T3Medcomp20132—
+1K111651Split Cath IiiMedical Components, Inc.201101
+1K051280Medcomp Split Cath IIMedcomp20051—
+1K040318Medcomp Split-Cath IIMedcomp20059—
+1K030020Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc.200312—
+1K022678Medcomp SC4Medcomp200311—
+2K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+2K130889Split Cath RGMedcomp20140—
+2K090101Equistream Long-Term Hemodialysis CathetersC.R. Bard, Inc.2009015
+2K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc.200773
+2K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc.20061—
+2K051748Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis CathetersC.R. Bard, Inc.2005813
+2K033294Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…C.R. Bard, Inc.200310—
+3K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+3K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…C. R. Bard20205—
+3K092597Centros Chronic Hemodialysis Catheter SetAsh Access Technology, Inc.20092—
+3K090528Duet Long-Term Hemodialysis Catheter System, Duet Long-Term Hemodialysis Catheter System…C.R. Bard, Inc.20090—
+3K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.200865
+3K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc.200702
+4K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.20210—
+4K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.20210—
+4K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc.20202—
+4K141363Centros Long Term Hemodialysis Catheter, Centrosflo Long Term Hemodialysis CatheterMerit Medical Systems, Inc.20141—
+4K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc.20102Class I
+5K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.20201—
+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
+6K241581Hemodialysis CatheterHaolang Medical USA Corporation20250—