End Cap
FDA 510(k) K210461 · Medical Components Inc (Medcomp)
510(k) numberK210461
Submission
- Device name
- End Cap
- Applicant
- Medical Components Inc (Medcomp)
Harleysville, PA, US - Received
- February 16, 2021
- Decision date
- September 14, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSD – Catheter, Hemodialysis, Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
- Life-sustaining
- Yes
Other 510(k)s with product code MSD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241581 | Hemodialysis CatheterMSD · Traditional | Haolang Medical USA Corporation | 05/16/2025SESK |
| K203575 | GlidePath Retro Long-Term Hemodialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 07/01/2021SESK |
| K211410 | GlidePath 13F Long-Term Hemodialysis CatheterMSD · Special | Bard Peripheral Vascular, Inc. | 06/04/2021SESK |
| K203767 | Pristine Long-Term Hemodialysis CatheterMSD · Traditional | C B Bard, Inc. | 04/02/2021SESK |
| K202150 | GlidePath 7.5F Long-Term Dialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 11/18/2020SESK |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMSD · Special | Medical Components, Inc. (dba MedComp) | 09/03/2020SE |
| K200627 | GlidePath 10F Long-Term Dialysis CatheterMSD · Traditional | C.R. Bard, Inc. | 06/22/2020SESK |
| K190527 | GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters…MSD · Traditional | C. R. Bard | 03/05/2020SESK |
| K182443 | Pristine Hemodialysis CatheterMSD · Traditional | Pristine Access Technologies , Ltd. | 05/31/2019SE |
| K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…MSD · Traditional | Medical Components, Inc. (dba MedComp) | 05/17/2018SESK |
Questions and answers
When was End Cap cleared by the FDA?
End Cap (K210461) received a 510(k) decision of Substantially Equivalent on September 14, 2021, 210 days after the submission was received.
What is the product code of K210461?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.