RENAFLO AVF SET FOR HEMODIALYSIS
FDA 510(k) clearance K834510 · decided 1984-02-04
Clearance details
- K-number
- K834510
- Device name
- RENAFLO AVF SET FOR HEMODIALYSIS
- Applicant
- Renal Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-21
- Decision date
- 1984-02-04
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- KNZ
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARGON DUAL LUMEN HEMODIALYSIS, CATHETER (K842039) | Argon Medical Corp. | 1985-01-29 |
| ACUTE HEMODIALYSIS TRAYS (K844612) | Packaging Technologies, Inc. | 1984-12-17 |
| VACCESS FEMORAL CANNULA (K842864) | Vas-Cath of Canada , Ltd. | 1984-08-08 |
| DUO FLOW CATHETER-MC 54 (K842416) | Medical Components, Inc. | 1984-07-26 |
| DOUBLE LUMEN SUBLCAVIAN-FEMORAL (K841530) | Medical Components, Inc. | 1984-06-25 |
| TOPS DISPOS. INFUSION SET/HEMODIALYSIS (K841119) | Top Surgical Manufacturers Co. | 1984-04-20 |
| HEMOCATH REPAIR KIT (K840424) | Quinton, Inc. | 1984-03-05 |
| HEMASITE ACCESSORIES MODIFICATION (K840437) | Renal Systems, Inc. | 1984-02-21 |
| ACUTE HEMODIALYSIS TRAYS (K833139) | Intermed, Inc. | 1983-12-22 |
Recalls involving this device
No recalls on record reference this clearance.