Dialyzer, Parallel Flow
FDA product code FJG · Class II (moderate risk) · 21 CFR 876.5820 · Gastroenterology, Urology
36510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Gambro, Inc. 7
- Cobe Laboratories, Inc. 4
- Hospal Medical Corp. 4
- Extracorporeal Medical Specialities, Inc. 4
- Medical, Inc. 3
- Cyberex Corp. 3
- Travenol Laboratories, S.A. 2
- Cobe Renal Care, Inc. 2
- Erika, Inc. 1
- Bellco Artifidial Organ Spec., Inc. 1
- Nikkiso Co., Ltd. 1
- Akcess Medical Products, Inc. 1
- Gambro-Hospal, Inc. 1
- C.G.H. Medical, Inc. 1
- National Medical Care, Medical Products Div., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933681 | Gambro Lundia Pro 100, 500, 600 DialyzersFJG · Traditional | Cobe Renal Care, Inc. | 09/07/1994SE |
| K933680 | Gambro Lundia Pro 200 DialyzerFJG · Traditional | Cobe Renal Care, Inc. | 08/26/1994SE |
| K920693 | Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional | National Medical Care, Medical Products Div., Inc. | 09/21/1992SE |
| K915504 | Gambro Lundia Alpha HemodialyzersFJG · Traditional | C.G.H. Medical, Inc. | 03/06/1992SE |
| K901368 | Hemospal Kits A1, A2D, Ao, & A1DFJG · Traditional | Gambro-Hospal, Inc. | 08/02/1990SE |
| K902203 | Tenckhoff Peritoneal Dialysis KitFJG · Traditional | Akcess Medical Products, Inc. | 08/01/1990SESK |
| K862840 | Gambro Lundia 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6NFJG · Traditional | Gambro, Inc. | 09/29/1986SE |
| K853406 | Gambro Lundia Pro 3 & 5 DialyzerFJG · Traditional | Gambro, Inc. | 01/08/1986SE |
| K820694 | Cobe PPD 1.3L, #18-520-009FJG · Traditional | Cobe Laboratories, Inc. | 03/31/1982SE |
| K812336 | Cobe PPD 1.9FJG · Traditional | Cobe Laboratories, Inc. | 08/31/1981SE |
| K811440 | Exp 600 Parallel Plate DialyzerFJG · Traditional | Extracorporeal Medical Specialities, Inc. | 06/12/1981SE |
| K811439 | Exp 200 Parallel Plate DialyzerFJG · Traditional | Extracorporeal Medical Specialities, Inc. | 06/12/1981SE |
| K810066 | Cobe PPD .8FJG · Traditional | Cobe Laboratories, Inc. | 06/09/1981SE |
| K810837 | Cyber 80 HemodialyzerFJG · Traditional | Cyberex Corp. | 05/05/1981SE |
| K802478 | Cyber 120 HemodialyzerFJG · Traditional | Cyberex Corp. | 03/20/1981SE |
| K803068 | Nikkiso ND-14 Parallel Flow DialyzerFJG · Traditional | Nikkiso Co., Ltd. | 03/04/1981SE |
| K802364 | Extracorporeal's Exp 400 Parallel PlateFJG · Traditional | Extracorporeal Medical Specialities, Inc. | 01/29/1981SE |
| K802389 | Gambro Lundia Plate Disp. DialyzerFJG · Traditional | Gambro, Inc. | 12/22/1980SE |
| K801633 | The Bravo New Parallel Flow DialyzerFJG · Traditional | Bellco Artifidial Organ Spec., Inc. | 12/18/1980SE |
| K801451 | Isonephros-Pediatric, Standard, OptimumFJG · Traditional | Medical, Inc. | 09/26/1980SE |
| K801377 | Cyber 120 HemodialyzerFJG · Traditional | Cyberex Corp. | 08/27/1980SE |
| K800424 | Lundia Plate Disp.FJG · Traditional | Gambro, Inc. | 04/10/1980SE |
| K792611 | Gambro Lundia Plate DialyzerFJG · Traditional | Gambro, Inc. | 02/06/1980SE |
| K791961 | Extracorporeal's Model EX-85 DialyzerFJG · Traditional | Extracorporeal Medical Specialities, Inc. | 11/13/1979SE |
| K791448 | Hemodialyzers RP-510 and RP-514FJG · Traditional | Hospal Medical Corp. | 08/07/1979SE |
| K790758 | Hemoclear U-Nephros 1.0 DialyzerFJG · Traditional | Medical, Inc. | 05/08/1979SE |
| K790533 | HD Capillary Film Dialyzer, Model 1001FJG · Traditional | Travenol Laboratories, S.A. | 05/02/1979SE |
| K790001 | Dialyzer, Model F.M.D 150FJG · Traditional | Hospal Medical Corp. | 03/06/1979SE |
| K781966 | Dialyzer, Magniflo 100 Parallel PlateFJG · Traditional | Erika, Inc. | 02/21/1979SE |
| K781795 | Dialyzer, Parallel Flow DisposableFJG · Traditional | Medical, Inc. | 12/15/1978SE |
| K780700 | Lundia Plate Disposable DialyzerFJG · Traditional | Gambro, Inc. | 07/17/1978SE |
| K780427 | RP-510/RP-514 Parallel Plate DialyzersFJG · Traditional | Hospal Medical Corp. | 05/19/1978SE |
| K772318 | Dialyzer Standard, Code 5DM1780FJG · Traditional | Travenol Laboratories, S.A. | 01/26/1978SE |
| K771354 | Parallel Plate DialyzersFJG · Traditional | Hospal Medical Corp. | 09/15/1977SE |
| K770858 | Dialyzer, Ultradiffuser, DisposableFJG · Traditional | Gambro, Inc. | 06/14/1977SE |
| K770578 | Parallel Plate DialyzerFJG · Traditional | Cobe Laboratories, Inc. | 04/15/1977SE |