Product code KNZ
- Device name
- Accessories, A-V Shunt
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5540
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842039 | ARGON DUAL LUMEN HEMODIALYSIS, CATHETER | Argon Medical Corp. | 1985-01-29 |
| K844612 | ACUTE HEMODIALYSIS TRAYS | Packaging Technologies, Inc. | 1984-12-17 |
| K842864 | VACCESS FEMORAL CANNULA | Vas-Cath of Canada , Ltd. | 1984-08-08 |
| K842416 | DUO FLOW CATHETER-MC 54 | Medical Components, Inc. | 1984-07-26 |
| K841530 | DOUBLE LUMEN SUBLCAVIAN-FEMORAL | Medical Components, Inc. | 1984-06-25 |
| K841119 | TOPS DISPOS. INFUSION SET/HEMODIALYSIS | Top Surgical Manufacturers Co. | 1984-04-20 |
| K840424 | HEMOCATH REPAIR KIT | Quinton, Inc. | 1984-03-05 |
| K840437 | HEMASITE ACCESSORIES MODIFICATION | Renal Systems, Inc. | 1984-02-21 |
| K834510 | RENAFLO AVF SET FOR HEMODIALYSIS | Renal Systems, Inc. | 1984-02-04 |
| K833139 | ACUTE HEMODIALYSIS TRAYS | Intermed, Inc. | 1983-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884908143072 | DUO-FLOW® | Medical Components, Inc. | 2019-06-25 |
| 00884908143058 | DUO-FLOW® | Medical Components, Inc. | 2019-06-25 |
| 00884908056808 | Soft-Line® Duo-Flow | Medical Components, Inc. | 2016-04-30 |
| 00884908056860 | Soft-Line® Duo-Flow | Medical Components, Inc. | 2016-04-30 |
| 00884908053937 | DUO-FLOW® | Medical Components, Inc. | 2016-03-10 |
| 00884908059564 | Duo-Flow® | Medical Components, Inc. | 2015-12-10 |
| 00884908061376 | DUO-FLOW® | Medical Components, Inc. | 2015-11-18 |
| 00884908058895 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908061444 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908061314 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908061161 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908061079 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908060041 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908059823 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908059380 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908059014 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908000184 | Duo-Flow®XTP | Medical Components, Inc. | 2015-11-14 |
| 00884908056174 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908037647 | Duo-Flow®XTP | Medical Components, Inc. | 2015-11-14 |
| 00884908037616 | Duo-Flow®XTP | Medical Components, Inc. | 2015-11-14 |
| 00884908026467 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908026443 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908026436 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908026429 | Duo-Flow® | Medical Components, Inc. | 2015-11-14 |
| 00884908000207 | Duo-Flow®XTP | Medical Components, Inc. | 2015-11-14 |
| 00884908000191 | Duo-Flow®XTP | Medical Components, Inc. | 2015-11-14 |
| 00884908058673 | DUO-FLOW® | Medical Components, Inc. | 2015-11-13 |
| 00884908060027 | DUO-FLOW® | Medical Components, Inc. | 2015-11-13 |
| 00884908061222 | Duo-Flow® | Medical Components, Inc. | 2015-11-13 |
| 00884908037623 | Duo-Flow® | Medical Components, Inc. | 2015-11-11 |