MSD — Catheter, Hemodialysis, Implanted Class II

FDA Device Classification

Classification Details

Product Code
MSD
Device Class
Class II
Regulation Number
876.5540
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241581haolang medical usa corporationHemodialysis CatheterMay 16, 2025
K210461medical components inc (medcomp)End CapSeptember 14, 2021
K203575c.r. bardGlidePath Retro Long-Term Hemodialysis CatheterJuly 1, 2021
K211410bard peripheral vascularGlidePath 13F Long-Term Hemodialysis CatheterJune 4, 2021
K203767c b bardPristine Long-Term Hemodialysis CatheterApril 2, 2021
K202150c.r. bardGlidePath 7.5F Long-Term Dialysis CatheterNovember 18, 2020
K202176medical components, inc. (dba medcomp)Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesSeptember 3, 2020
K200627c.r. bardGlidePath 10F Long-Term Dialysis CatheterJune 22, 2020
K190527c. r. bardGlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis CathMarch 5, 2020
K182443pristine access technologiesPristine Hemodialysis CatheterMay 31, 2019
K173667medical components, inc. (dba medcomp)15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 2May 17, 2018
K173805marvao medical devicesNexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSiteFebruary 8, 2018
K171571marvao medical devicesNexSite HD, Hemodialysis Step Tip Catheter (60cm)November 30, 2017
K171618medcomp (dba medical components, inc.)Symetrex Long Term Hemodialysis CatheterNovember 16, 2017
K161026marvao medical devicesNexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cAugust 9, 2016
K151967merit medical systemsCentros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheApril 4, 2016
K143567marvao medical devicesNexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD March 31, 2015
K140884phase one medicalSYMETREX LONG TERM HEMODIALYSIS CATHETERNovember 26, 2014
K140492marvao medical devicesNEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USENovember 13, 2014
K141051arrow internationalVECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIALJuly 7, 2014