FDA.reportPublic FDA data

510(k) K202150

Device
GlidePath 7.5F Long-Term Dialysis Catheter
Applicant
C.R. Bard, Inc.
510(k) number
K202150
Product code
MSD
Decision
Unknown (SESK)
Decision date
2020-11-18
Date received
2020-08-03
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
Joan Bergstrom
Address
1625 W Third St. Tempe AZ US 85281 85281

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
K210461End CapMedical Components Inc (Medcomp)2021-09-14
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
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