FDA Product Code
FDA Product Code FJI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 131 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K801826 | RENAFLO HOLLOW FIBER DIALYZERS #MP 140 | Renal Systems, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801827 | RENAFLO HOLLOW FIBER DIALYZER #100.1 | Renal Systems, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801825 | RENAFLO HOLLOW FIBER DIALYZERS S.M.A.D. | Renal Systems, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801194 | CLIRANS TE07 HOLLOW FIBER DIALYZER | Terumo America, Inc. | 1980-08-12 | Traditional | PDF ↗ |
| K801192 | CLIRANS TE10 HOLLOW FIBER DIALYZER | Terumo America, Inc. | 1980-08-12 | Traditional | PDF ↗ |
| K801178 | COBE HF80, CAT. #18-580 | Cobe Laboratories, Inc. | 1980-07-28 | Traditional | PDF ↗ |
| K801370 | GF-120-L DIALYZER | Gambro, Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K801344 | EXTRACORPOREALS' ALTERNATE MEMBRANE | Extracorporeal Medical Specialities, Inc. | 1980-07-21 | Traditional | PDF ↗ |
| K801045 | GF120H DIALYZER | Gambro, Inc. | 1980-06-30 | Traditional | PDF ↗ |
| K800704 | C-DAK TM 2800 ARTIFICIAL KIDNEY | Cordis Corp. | 1980-05-08 | Traditional | PDF ↗ |
| K800336 | GAMBRO LUNDIA FIBER | Gambro, Inc. | 1980-05-02 | Traditional | PDF ↗ |
| K800549 | MODEL TRIEX-L HOLLOW FIBER DIALYZER | Extracorporeal Medical Specialities, Inc. | 1980-04-10 | Traditional | PDF ↗ |
| K800270 | TRIEX-2 HOLLOW FIBER DIALYZER | Extracorporeal Medical Specialities, Inc. | 1980-02-26 | Traditional | PDF ↗ |
| K800221 | CF/211 CAPILLARY FLOW DIALYZER, #5M1784 | Travenol Laboratories, S.A. | 1980-02-26 | Traditional | PDF ↗ |
| K792419 | C-DAK 2100 ARTIFICIAL KIDNEY | Cordis Corp. | 1980-01-16 | Traditional | PDF ↗ |
| K791321 | ERIKA HPF 200 | Erika, Inc. | 1979-09-24 | Traditional | PDF ↗ |
| K791320 | ERIKA HPF 100 | Erika, Inc. | 1979-09-24 | Traditional | PDF ↗ |
| K791322 | ERIKA HPF 300 | Erika, Inc. | 1979-09-24 | Traditional | PDF ↗ |
| K790696 | RDI-1 HOLLOW FIBER DIALYZER | Renal Devices, Inc. | 1979-06-20 | Traditional | PDF ↗ |
| K790308 | DISPOSABLE DIALYZERS, SD-ID, SD-2D | Bentley Laboratories, Inc. | 1979-05-01 | Traditional | PDF ↗ |
| K790067 | FLOW DIALYZER, CF 2300 CAPILLARY | Travenol Laboratories, S.A. | 1979-04-10 | Traditional | PDF ↗ |
| K782151 | ARTIFICIAL KIDNEY, C-DAK 0.6D | Cordis Corp. | 1979-02-22 | Traditional | PDF ↗ |
| K781142 | DISSCAP | Hospal Medical Corp. | 1978-09-14 | Traditional | PDF ↗ |
| K781058 | C-DAK 4000 ARTIFICIAL KIDNEY | Cordis Corp. | 1978-08-23 | Traditional | PDF ↗ |
| K772290 | DIALYZER, CAPILATORY, HOLLOW FIBER | Redy Laboratories | 1978-03-15 | Traditional | PDF ↗ |
| K772423 | SPIRAFLOW DIALYZERS | Bentley Laboratories, Inc. | 1978-01-26 | Traditional | PDF ↗ |
| K771694 | CLIRANS TH 15 HOLLOW FIBER DIALYZER | Terumo America, Inc. | 1977-09-15 | Traditional | PDF ↗ |
| K770867 | DIALYZER, FIBER, HOLLOW | Cobe Laboratories, Inc. | 1977-06-14 | Traditional | PDF ↗ |
| K770734 | DIALYZER, FIBER, HOLLOW | Travenol Laboratories, S.A. | 1977-05-10 | Traditional | PDF ↗ |
| K761007 | ARTIFICIAL KIDNEY, C-DAK CORDIS DOW | Cordis Corp. | 1977-01-12 | Traditional | PDF ↗ |
| K760252 | DIALYZER, HF 130 HOLLOW FIBER | Cobe Laboratories, Inc. | 1976-10-15 | Traditional | PDF ↗ |
Product code FJI · Class II · Gastroenterology, Urology. Data: openFDA.