Niagara Dual Lumen Catheter
FDA 510(k) K965178 · Vas-Cath, Inc.
510(k) numberK965178
Submission
- Device name
- Niagara Dual Lumen Catheter
- Applicant
- Vas-Cath, Inc.
Ontario, L5a 3v3, CA - Received
- December 24, 1996
- Decision date
- August 19, 1997
- Decision
- Substantially Equivalent (SESE)
- 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
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| 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 |
| K110793 | Amecath and Amecath Uniqath Soft Short Term Dual Hemodialysis Catheterization KitsMPB · Traditional | Ameco Medical Industries | 12/16/2011SE |
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| K970725 | Opti-Plast XL 5.5 F Pta CatheterLIT · Traditional | 05/09/1997SE |
| K941706 | Opti-Plast Angioplasty CatheterLIT · Traditional | 10/18/1994SE |
| K925485 | Vas-Cath Inc. Opti-Plast Angioplasty CatheterLIT · Traditional | 03/10/1994SE |
| K933483 | Opti-Plast 5F Pta CathetersLIT · Traditional | 09/24/1993SE |
| K914210 | Vas-Cath Dualator(Tm) Vessel DilatorFKA · Traditional | 07/01/1993SE |
| K914162 | Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersLFJ · Traditional | 07/01/1993SE |
| K914976 | Opti-Plast 5F Pta Catheters, ModificationLIT · Traditional | 01/27/1992SE |
| K914500 | Opti-Plast 5F Pta Catheters, ModificationLIT · Traditional | 12/31/1991SE |
Questions and answers
When was Niagara Dual Lumen Catheter cleared by the FDA?
Niagara Dual Lumen Catheter (K965178) received a 510(k) decision of Substantially Equivalent on August 19, 1997, 238 days after the submission was received.
What is the product code of K965178?
The FDA product code is MPB – Catheter, Hemodialysis, Non-Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.