MSD — Catheter, Hemodialysis, Implanted Class II
FDA product code MSD covers "Catheter, Hemodialysis, Implanted", a Class II medical device regulated under 21 CFR 876.5540. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241581 | Haolang Medical Usa Corporation | Hemodialysis Catheter | May 16, 2025 |
| K210461 | Medical Components Inc (Medcomp) | End Cap | Sep 14, 2021 |
| K203575 | C.R. Bard | GlidePath Retro Long-Term Hemodialysis Catheter | Jul 1, 2021 |
| K211410 | Bard Peripheral Vascular | GlidePath 13F Long-Term Hemodialysis Catheter | Jun 4, 2021 |
| K203767 | C B Bard | Pristine Long-Term Hemodialysis Catheter | Apr 2, 2021 |
| K202150 | C.R. Bard | GlidePath 7.5F Long-Term Dialysis Catheter | Nov 18, 2020 |
| K202176 | Medical Components, Inc. (Dba Medcomp) | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes | Sep 3, 2020 |
| K200627 | C.R. Bard | GlidePath 10F Long-Term Dialysis Catheter | Jun 22, 2020 |
| K190527 | C. R. Bard | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Cath | Mar 5, 2020 |
| K182443 | Pristine Access Technologies | Pristine Hemodialysis Catheter | May 31, 2019 |
| K173667 | Medical Components, Inc. (Dba Medcomp) | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 2 | May 17, 2018 |
| K173805 | Marvao Medical Devices | NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite | Feb 8, 2018 |
| K171571 | Marvao Medical Devices | NexSite HD, Hemodialysis Step Tip Catheter (60cm) | Nov 30, 2017 |
| K171618 | Medcomp (Dba Medical Components, Inc.) | Symetrex Long Term Hemodialysis Catheter | Nov 16, 2017 |
| K161026 | Marvao Medical Devices | NexSite HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 c | Aug 9, 2016 |
| K151967 | Merit Medical Systems | Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Cathe | Apr 4, 2016 |
| K143567 | Marvao Medical Devices | NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD | Mar 31, 2015 |
| K140884 | Phase One Medical | SYMETREX LONG TERM HEMODIALYSIS CATHETER | Nov 26, 2014 |
| K140492 | Marvao Medical Devices | NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE | Nov 13, 2014 |
| K141051 | Arrow International | VECTORFLOW; ANTEGRADE CHRONIC HEMODIALYSIS CATHETER, RETROGRADE CHRONIC HEMODIAL | Jul 7, 2014 |