Renaflo Avf Set for Hemodialysis
FDA 510(k) K834510 · Renal Systems, Inc.
510(k) numberK834510
Submission
- Device name
- Renaflo Avf Set for Hemodialysis
- Applicant
- Renal Systems, Inc.
Mchenry, IL, US - Received
- December 21, 1983
- Decision date
- February 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNZ – Accessories, A-V Shunt
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5540
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
Other 510(k)s with product code KNZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K842039 | Argon Dual Lumen Hemodialysis, CatheterKNZ · Traditional | Argon Medical Corp. | 01/29/1985SE |
| K844612 | Acute Hemodialysis TraysKNZ · Traditional | Packaging Technologies, Inc. | 12/17/1984SE |
| K842864 | Vaccess Femoral CannulaKNZ · Traditional | Vas-Cath of Canada , Ltd. | 08/08/1984SE |
| K842416 | Duo Flow Catheter-Mc 54KNZ · Traditional | Medical Components, Inc. | 07/26/1984SE |
| K841530 | Double Lumen Sublcavian-FemoralKNZ · Traditional | Medical Components, Inc. | 06/25/1984SE |
| K841119 | Tops Dispos. Infusion Set/HemodialysisKNZ · Traditional | Top Surgical Manufacturers Co. | 04/20/1984SE |
| K840424 | Hemocath Repair KitKNZ · Traditional | Quinton, Inc. | 03/05/1984SE |
| K840437 | Hemasite Accessories ModificationKNZ · Traditional | Renal Systems, Inc. | 02/21/1984SE |
| K833139 | Acute Hemodialysis TraysKNZ · Traditional | Intermed, Inc. | 12/22/1983SE |
More from Intermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970648 | Primus Hollow Fiber Dialyzer (Models 1000,1000S,1350,1350S,2000,2000S)MSF · Traditional | 01/05/1998SE |
| K861730 | Actril for Kidney Machine DisinfectantFKQ · Traditional | 06/09/1987SE |
| K854011 | Renalfo Hemofilter CavhdKDI · Traditional | 11/05/1985SE |
| K844790 | Renaflo HemoconcentratorKDI · Traditional | 05/23/1985SE |
| K844108 | Renal Systems Peritoneal Access SystemFKX · Traditional | 01/07/1985SE |
| K843963 | Dialysate Concentrate for Hemodialysis-Liquid/PowdFKQ · Traditional | 01/07/1985SE |
| K842258 | RenatronLIF · Traditional | 07/06/1984SE |
| K841543 | Concentrate Conductivity MeterFKQ · Traditional | 05/22/1984SE |
| K840182 | Renapak Concentrate Mixing Sys.FKQ · Traditional | 05/02/1984SE |
| K840437 | Hemasite Accessories ModificationKNZ · Traditional | 02/21/1984SE |
Questions and answers
When was Renaflo Avf Set for Hemodialysis cleared by the FDA?
Renaflo Avf Set for Hemodialysis (K834510) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 45 days after the submission was received.
What is the product code of K834510?
The FDA product code is KNZ – Accessories, A-V Shunt, a Class II (moderate risk) device regulated under 21 CFR 876.5540.