Acute Dual Lumen Hemodialysis Catheter
FDA 510(k) K200426 · Health Line International Corporation
510(k) numberK200426
Submission
- Device name
- Acute Dual Lumen Hemodialysis Catheter
- Applicant
- Health Line International Corporation
Salt Lake City, UT, US - Received
- February 21, 2020
- Decision date
- December 24, 2020
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K110793 | Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization KitsMPB · Traditional | Ameco Medical Industries | 12/16/2011SE |
| 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 |
|---|---|---|
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | 06/22/2026SE |
| K222170 | Power Acute Triple Lumen Hemodialysis CatheterNIE · Traditional | 01/13/2023SE |
| K200263 | Health Line CT Midline CatheterFOZ · Special | 03/12/2020SE |
| K192533 | Health Line CT CVCFOZ · Traditional | 12/10/2019SE |
| K160448 | ArtlineDQY · Traditional | 07/12/2016SE |
| K140270 | Nexus Midline CT CatheterFOZ · Traditional | 08/20/2014SE |
| K130851 | Cascade Hemodialysis/Apheresis CatheterMSD · Traditional | 01/09/2014SESK |
| K130034 | Uni-PiccLJS · Traditional | 03/08/2013SE |
| K120548 | Hlic Needle-Less ValveFPA · Traditional | 05/04/2012SE |
| K101329 | Synergy CT PiccLJS · Traditional | 08/19/2010SE |
Questions and answers
When was Acute Dual Lumen Hemodialysis Catheter cleared by the FDA?
Acute Dual Lumen Hemodialysis Catheter (K200426) received a 510(k) decision of Unknown on December 24, 2020, 307 days after the submission was received.
What is the product code of K200426?
The FDA product code is MPB – Catheter, Hemodialysis, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.