FDA Product Code
FDA Product Code KDI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5860
510(k) Clearances — 345 records · page 4 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K854309 | GAMBRO BLOOD CONCENTRATOR SETS 16,60,200 | Gambro, Inc. | 1985-12-13 | Traditional | PDF ↗ |
| K854586 | HOLLOW FIBER DIALYZER | Travenol Laboratories, S.A. | 1985-12-13 | Traditional | PDF ↗ |
| K854011 | RENALFO HEMOFILTER CAVHD | Renal Systems, Inc. | 1985-11-05 | Traditional | PDF ↗ |
| K853510 | MINIFILTER HEMOFILTER | Amicon, Inc. | 1985-09-12 | Traditional | PDF ↗ |
| K852885 | FILTRAL HEMODIALYZER | Hospal Medical Corp. | 1985-09-06 | Traditional | PDF ↗ |
| K853333 | DIMENSION TOTAL HIP PROSTHESIS | Kirschner Medical Corp. | 1985-09-03 | Traditional | PDF ↗ |
| K850979 | HEMOCONCENTRATOR KIT | Omnis Surgical, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K852251 | FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40 | Seratronics, Inc. | 1985-07-25 | Traditional | PDF ↗ |
| K844790 | RENAFLO HEMOCONCENTRATOR | Renal Systems, Inc. | 1985-05-23 | Traditional | PDF ↗ |
| K850866 | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L | Erika, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K844663 | ASAHI NEW PAN-SERIES HEMOFILTERS | Asahi Medical Co., Ltd. | 1985-01-18 | Traditional | PDF ↗ |
| K841585 | AMER. BENTLEY CONTINU-BLOOD PROCESSOR- | American Bentley | 1984-10-18 | Traditional | PDF ↗ |
| K843014 | FRESENIUS HAEMODIALYSIS A2008 | Seratronics, Inc. | 1984-10-18 | Traditional | PDF ↗ |
| K841152 | HOSPAL BIOSPAL SCU/CAVH KIT | Hospal Medical Corp. | 1984-07-06 | Traditional | PDF ↗ |
| K840680 | CENTRY 2000 DIALYSIS CONTROL UNIT | Cobe Laboratories, Inc. | 1984-04-20 | Traditional | PDF ↗ |
| K840449 | AMICON DIAFILTER 40. HEMOFILTER | Medical Device Consultants, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K840543 | BLOOD CONCENTRATOR 140 | Gambro, Inc. | 1984-03-23 | Traditional | PDF ↗ |
| K831784 | HEMOFILTRATION SYSTEM | Gambro, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K834589 | BIOSPAL (R) 1800S | Hospal Medical Corp. | 1984-02-04 | Traditional | PDF ↗ |
| K832547 | ULTRAFILTRATION CONTROLLER | Extracorporeal Medical Specialities, Inc. | 1984-01-03 | Traditional | PDF ↗ |
| K832659 | BIOSPAL 1200S | Hospal Medical Corp. | 1983-09-20 | Traditional | PDF ↗ |
| K832645 | BIOSPAL 3000 S | Hospal Medical Corp. | 1983-09-20 | Traditional | PDF ↗ |
| K830487 | HEMO-PROCESSING SYSTEM | Sartorius Filters, Inc. | 1983-04-28 | Traditional | PDF ↗ |
| K830595 | MONITRAL | Hospal Medical Corp. | 1983-04-28 | Traditional | PDF ↗ |
| K830596 | ULTRAFILTRATION MONITOR UFM-10-2 | Gambro, Inc. | 1983-04-27 | Traditional | PDF ↗ |
| K830648 | H1207 | Hospal Medical Corp. | 1983-03-29 | Traditional | PDF ↗ |
| K830647 | H1210 | Hospal Medical Corp. | 1983-03-29 | Traditional | PDF ↗ |
| K830284 | FH 101, FH 202 & FH 303 FIBER HEMOFILTER | Gambro, Inc. | 1983-03-02 | Traditional | PDF ↗ |
| K823881 | ARTERIOVENOUS BLOOD TUBING SET FOR | Amicon, Inc. | 1983-01-17 | Traditional | PDF ↗ |
| K823338 | COBE HEMOCONCENTRATOR 1.3 | Cobe Laboratories, Inc. | 1983-01-07 | Traditional | PDF ↗ |
| K823589 | H 12 07 | Hospal Medical Corp. | 1982-12-22 | Traditional | PDF ↗ |
| K823288 | AMICON DIAFILTERS 20 & 30 HEMOFILTERS | Amicon, Inc. | 1982-12-16 | Traditional | PDF ↗ |
| K813591 | HEMOFILTERS | Amicon, Inc. | 1982-03-31 | Traditional | PDF ↗ |
| K820243 | CONTINUOUS BLOOD PROCESSOR CBP-6000 & | Bentley Laboratories, Inc. | 1982-03-25 | Traditional | PDF ↗ |
| K812575 | MODEL H12-10 | Hospal Medical Corp. | 1981-10-19 | Traditional | PDF ↗ |
| K811830 | C-DAK DUO-FLUX ARTIFICIAL KIDNEY | Cordis Corp. | 1981-09-21 | Traditional | PDF ↗ |
| K811944 | GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER | Gambro, Inc. | 1981-08-31 | Traditional | PDF ↗ |
| K801479 | GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL- | Gambro, Inc. | 1980-08-27 | Traditional | PDF ↗ |
| K801480 | GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ | Gambro, Inc. | 1980-08-27 | Traditional | PDF ↗ |
| K801731 | C-DAK DUO-FLUX ARTIFICIAL KIDNEY | Cordis Corp. | 1980-08-13 | Traditional | PDF ↗ |
| K800536 | MODEL H 607-.67M2 30 MICRON RP AN69 MEM | Hospal Medical Corp. | 1980-08-07 | Traditional | PDF ↗ |
| K801303 | MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST | Western Laboratories Corp. | 1980-07-28 | Traditional | PDF ↗ |
| K790827 | RP-610 PARALLEL PLATE DIALYZER | Hospal Medical Corp. | 1979-09-04 | Traditional | PDF ↗ |
| K780527 | CORTRAL I | Hospal Medical Corp. | 1978-12-20 | Traditional | PDF ↗ |
| K781464 | HEMODIALYZER, MODEL RP610, RP AN 69 | Hospal Medical Corp. | 1978-12-20 | Traditional | PDF ↗ |
Product code KDI · Class II · Gastroenterology, Urology. Data: openFDA.