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MPB — Catheter, Hemodialysis, Non-Implanted Class II

FDA Device Classification

Classification Details

Product Code
MPB
Device Class
Class II
Regulation Number
876.5540
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250836medical components14F Duo-Flow® Side X Side Double Lumen CatheterAugust 12, 2025
K200426health line international corporationAcute Dual Lumen Hemodialysis CatheterDecember 24, 2020
K192807medical components, inc. (dba medcomp)Duo-Flow Side x Side Double Lumen CatheterApril 23, 2020
K192302covidienMahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, MahurkJanuary 17, 2020
K163458c.r. bardZenysis Short-Term Dialysis CatheterApril 4, 2017
K161504cook incorporatedCook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayJanuary 6, 2017
K153190c.r. bardZenysis Short-Term Dialysis CatheterJanuary 5, 2016
K122091cookCOOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HJuly 29, 2013
K120674covidienMAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETERApril 4, 2012
K110793ameco medical industriesAMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KIDecember 16, 2011
K102833foshan nanhai bai he medical technology coDISPOSABLE HEMODIALYSIS ACCESS CATHETER SETSNovember 18, 2011
K100451gambro renal productsGAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOWDecember 21, 2010
K090102c.r. bardNIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS February 12, 2009
K071145nipro medical corporationNIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLESeptember 7, 2007
K063355novosciD-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOWJuly 27, 2007
K070234jms north americaJMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETSMay 22, 2007
K040301gambro renal productsGAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX ANovember 1, 2004
K030268c.r. bardNIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETJuly 30, 2003
K030209kendallMAHURKAR OPLUS CATHETER, MODEL 13.5 FRMay 13, 2003
K022221deltecTRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERSJanuary 30, 2003