510(k) Report

Devices descending from K010778

18 later devices reach Niagara Slim-Cath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163458Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20170—
+1K153190Zenysis Short-Term Dialysis CatheterC.R. Bard, Inc.20160—
+1K083675Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc.200912—
+1K090102Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis CathetersC.R. Bard, Inc.20091Class I
+1K040301Gamcath High Flow Catheter, Ref: GDHK 13XX aGambro Renal Products20041—
+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—
+2K102833Disposable Hemodialysis Access Catheter SetsFoshan Nanhai Bai HE Medical Technology Co., Ltd.20110—
+2K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca20107Class I
+2K100451Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…Gambro Renal Products, Inc.20100—
+3K222170Power Acute Triple Lumen Hemodialysis CatheterHealth Line International Corporation20230—
+3K192302Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…Covidien, LLC202006
+3K183219Trio-CT Triple Lumen CatheterMedical Components, Inc. (dba MedComp)20191—
+3K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc.20151Class I
+3K120674Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterCovidien201212
+4K232945Trio-CT­® Triple Lumen Catheter w/ Curved ExtensionsMedical Components, Inc. (dba MedComp)20230—
+4K200426Acute Dual Lumen Hemodialysis CatheterHealth Line International Corporation20200—