FKQ — System, Dialysate Delivery, Central Multiple Patient Class II
FDA product code FKQ covers "System, Dialysate Delivery, Central Multiple Patient", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FKQ
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052764 | b. braun medizintechnologie | DIACAP ULTRA DIALYSIS FLUID FILTER | June 9, 2006 |
| K893612 | national medical care, medical products div | TWO TANK DISSOLUTION MODULE | July 24, 1989 |
| K874084 | national medical care, medical products div | MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM | April 27, 1988 |
| K873421 | kawasumi laboratories co | KAWASUMI A.V. FISTULA SET | October 9, 1987 |
| K870889 | d.r.g. scientific industries | ACID FUCHSIN SOLUTIONS | July 8, 1987 |
| K861730 | renal systems | ACTRIL FOR KIDNEY MACHINE DISINFECTANT | June 9, 1987 |
| K864635 | national medical care, medical products div | FOUR TANK DISSOLUTION MODULE | January 13, 1987 |
| K862304 | cd medical | DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM | September 9, 1986 |
| K861472 | national medical care, medical products div | MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 | July 10, 1986 |
| K852359 | amuchina intl | AMUCHINA/DIALYZER DISINFECTANT | May 13, 1986 |
| K860297 | renal hygienics | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES | March 4, 1986 |
| K860296 | physicians surgeons purchasing group | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES | March 4, 1986 |
| K860336 | breem laboratories | HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS | March 4, 1986 |
| K854391 | dana laboratories | HEMODIALYSIS CONCENTRATE | January 8, 1986 |
| K852749 | mesa medical | RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT | September 10, 1985 |
| K852310 | erika | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK | July 26, 1985 |
| K844734 | alcide | ALCIDE REN NEW-D | May 17, 1985 |
| K844850 | medicorp | MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT | April 2, 1985 |
| K844750 | seratronics | FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD | February 15, 1985 |
| K844641 | seratronics | FRESENIUS HAEMODIALYSIS ;MACHINE A1008 | February 14, 1985 |