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510(k) K210461

Device
End Cap
Applicant
Medical Components Inc (Medcomp)
510(k) number
K210461
Product code
MSD
Decision
Substantially Equivalent (SESE)
Decision date
2021-09-14
Date received
2021-02-16
Regulation
876.5540
Classification name
Catheter, Hemodialysis, Implanted
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Patrick McDonald
Address
1499 Delp Dr. Harleysville PA US 19438 19438

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241581Hemodialysis CatheterHaolang Medical USA Corporation2025-05-16
K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc.2021-07-01
K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc.2021-06-04
K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc.2021-04-02
K202150GlidePath 7.5F Long-Term Dialysis CatheterC.R. Bard, Inc.2020-11-18
K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp)2020-09-03
K200627GlidePath 10F Long-Term Dialysis CatheterC.R. Bard, Inc.2020-06-22
K190527GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis CathetersC. R. Bard2020-03-05
K182443Pristine Hemodialysis CatheterPristine Access Technologies , Ltd.2019-05-31
K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with SideholesMedical Components, Inc. (dba MedComp)2018-05-17
K173805NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm)Marvao Medical Devices, Ltd.2018-02-08
K171571NexSite HD, Hemodialysis Step Tip Catheter (60cm)Marvao Medical Devices, Ltd.2017-11-30
K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.)2017-11-16
K161026NexSite™ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm)Marvao Medical Devices, Ltd.2016-08-09
K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc.2016-04-04