Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits
FDA 510(k) K110793 · Ameco Medical Industries
510(k) numberK110793
Submission
- Device name
- Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits
- Applicant
- Ameco Medical Industries
Mason, NH, US - Received
- March 22, 2011
- Decision date
- December 16, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MPB – Catheter, Hemodialysis, Non-Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code MPB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250836 | 14F Duo-Flow® Side X Side Double Lumen CatheterMPB · Traditional | Medical Components, Inc. | 08/12/2025SE |
| K200426 | Acute Dual Lumen Hemodialysis CatheterMPB · Traditional | Health Line International Corporation | 12/24/2020SESK |
| K192807 | Duo-Flow Side x Side Double Lumen CatheterMPB · Traditional | Medical Components, Inc. (dba MedComp) | 04/23/2020SE |
| K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…MPB · Traditional | Covidien, LLC | 01/17/2020SEKD |
| K163458 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | C.R. Bard, Inc. | 04/04/2017SEKD |
| K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayMPB · Special | Cook Incorporated | 01/06/2017SEKD |
| K153190 | Zenysis Short-Term Dialysis CatheterMPB · Traditional | C.R. Bard, Inc. | 01/05/2016SE |
| K122091 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…MPB · Traditional | Cook, Inc. | 07/29/2013SESK |
| K120674 | Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterMPB · Special | Covidien | 04/04/2012SESK |
| K102833 | Disposable Hemodialysis Access Catheter SetsMPB · Traditional | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 11/18/2011SE |
More from Foshan Nanhai Bai HE Medical Technology Co., 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 |
| K131814 | Amecath Dual Lumen Implanted Hemodialysis CatheterMSD · Special | 07/26/2013SESK |
| 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 |
Questions and answers
When was Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits cleared by the FDA?
Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization Kits (K110793) received a 510(k) decision of Substantially Equivalent on December 16, 2011, 269 days after the submission was received.
What is the product code of K110793?
The FDA product code is MPB – Catheter, Hemodialysis, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.