510(k) Report

Devices descending from K020089

15 later devices reach Mahurkar Triple Lumen Catheter, 12 FR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC202006
+1K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca20107Class I
+1K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc.200912—
+1K033570Medcomp T-3Medcomp20044—
+2K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation20230—
+2K18117512F Tri-Flow Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20180—
+2K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.)20150Class I
+2K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc.20142Class I
+2K123292T3Medcomp20132—
+2K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien201212
+3K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation20200—
+3K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+3K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc.20151Class I
+4K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+4K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20160—