Amecath Dual Lumen Implanted Hemodialysis Catheter
FDA 510(k) K131814 · Ameco Medical Industries
510(k) numberK131814
Submission
- Device name
- Amecath Dual Lumen Implanted Hemodialysis Catheter
- Applicant
- Ameco Medical Industries
Monroe, CT, US - Received
- June 20, 2013
- Decision date
- July 26, 2013
- Decision
- Unknown (SESK)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| K210461 | End CapMSD · Traditional | Medical Components Inc (Medcomp) | 09/14/2021SE |
| 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 |
More from Pristine Access Technologies , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K152819 | Amecath Peripheral inserted Central Venous Catheter SetsLJS · Traditional | 02/05/2016SE |
| K131144 | Ameco Sheath IntroducerDYB · Traditional | 08/15/2013SE |
| K123943 | Amecath Dual Lumen Hemodialysis CatheterMSD · Traditional | 04/02/2013SE |
| K110794 | Amecath CVC and Amecath Pressure CVC Short Term Single and Multi-Lumen Catherization KitsFOZ · Traditional | 12/21/2011SE |
| K110793 | Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization KitsMPB · Traditional | 12/16/2011SE |
Questions and answers
When was Amecath Dual Lumen Implanted Hemodialysis Catheter cleared by the FDA?
Amecath Dual Lumen Implanted Hemodialysis Catheter (K131814) received a 510(k) decision of Unknown on July 26, 2013, 36 days after the submission was received.
What is the product code of K131814?
The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.