Panels › Gastroenterology, Urology › Product code FKQ · Class 2
System, Dialysate Delivery, Central Multiple Patient
Regulation 876.5820
0510(k)s in 12 months (61 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FKQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Hospal Medical Corp. | 7 | 0 |
| Travenol Laboratories, S.A. | 5 | 0 |
| Extracorporeal Medical Specialities, Inc. | 4 | 0 |
| National Medical Care, Medical Products Div., Inc. | 4 | 0 |
| Renal Systems, Inc. | 4 | 0 |
| Erika, Inc. | 2 | 0 |
| Organon Teknika Corp. | 2 | 0 |
| Seratronics, Inc. | 2 | 0 |
| Alan P. Kendal, Ph.D. | 1 | 0 |
| Alcide Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 23, 1981 | K811444 | MODEL DM-333 DIALYSIS CONTROL STATION Extracorporeal Medical Specialities, Inc. | FKQ |
| May 1, 1981 | K802297 | PORTADIAL CARRY-ON KIDNEY MACHINE Alan P. Kendal, Ph.D. | FKQ |
| Apr 29, 1981 | K810612 | HEMOPHRON Renal Devices, Inc. | FKQ |
| Mar 20, 1981 | K810315 | ALTERNATE STERILIZ. FOR CELLULOSE ACET Cordis Corp. | FKQ |
| May 20, 1980 | K800771 | MOD. DM-356 IPS INTERFACE MODULE Extracorporeal Medical Specialities, Inc. | FKQ |
| Mar 12, 1980 | K792252 | DMS 3000 Renal Care Corp. | FKQ |
| Sep 7, 1978 | K781176 | PATIENT AID, MODEL DM-351 Extracorporeal Medical Specialities, Inc. | FKQ |
| Mar 31, 1978 | K780081 | DIALYZING FLUIDE DELIVERY SYSTEM Travenol Laboratories, S.A. | FKQ |
| Jan 3, 1978 | K772161 | HEMODIALYSIS APPARATUS Heald Manufacturing, Inc. | FKQ |
| Sep 15, 1977 | K771375 | PRESSURE MODULE 5M1247 Travenol Laboratories, S.A. | FKQ |
| Dec 6, 1976 | K760965 | BEDSIDE CONSOLES (11-3-910 & 11-3-930) Seattle Artificial Kidney Supply Co. | FKQ |
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