Acute Hemodialysis Trays
FDA 510(k) K833139 · Intermed, Inc.
510(k) numberK833139
Submission
- Device name
- Acute Hemodialysis Trays
- Applicant
- Intermed, Inc.
Mchenry, IL, US - Received
- September 14, 1983
- Decision date
- December 22, 1983
- 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 |
| K834510 | Renaflo Avf Set for HemodialysisKNZ · Traditional | Renal Systems, Inc. | 02/04/1984SE |
More from Renal Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K900857 | Non Sterile Parenteral Supply KitFMF · Traditional | 05/22/1990SEKD |
| K842166 | Intermed, Ins Sterile Water/SalineBSY · Traditional | 02/12/1985SE |
| K833126 | Dressing Change Trays · Traditional | 01/27/1984SE |
| K833574 | Percutaneous Sheath Introducer TraysDQX · Traditional | 01/11/1984SE |
| K833573 | Central Vein Cath. Tray CC-20-1420DQY · Traditional | 01/11/1984SE |
| K833059 | Suction Catheter TraysGBZ · Traditional | 12/12/1983SE |
| K821269 | Tracheostomy Care TraysEQN · Traditional | 05/27/1982SE |
| K791427 | Catheterization Trays Foley and UrethralKOD · Traditional | 09/07/1979SE |
| K791426 | Peritoneal PacKDJ · Traditional | 08/28/1979SE |
| K781748 | Irrigation TrayEYN · Traditional | 12/12/1978SE |
Questions and answers
When was Acute Hemodialysis Trays cleared by the FDA?
Acute Hemodialysis Trays (K833139) received a 510(k) decision of Substantially Equivalent on December 22, 1983, 99 days after the submission was received.
What is the product code of K833139?
The FDA product code is KNZ – Accessories, A-V Shunt, a Class II (moderate risk) device regulated under 21 CFR 876.5540.