FJI — Dialyzer, Capillary, Hollow Fiber Class II
FDA Device Classification
Classification Details
- Product Code
- FJI
- 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 |
|---|
| K190459 | fresenius medical care renal therapies group | Hemoflow F3 and F4 Dialyzers | August 23, 2019 |
| K122952 | nipro medical corporation | NIPRO PUREFLUX-L HEMODIALYZER | December 4, 2013 |
| K043342 | gambro renal products | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS | May 27, 2005 |
| K010366 | molded products | DISPOSABLE STORAGE CAP | November 28, 2001 |
| K011148 | interpore cross intl | ULTRACONCENTRATOR SYSTEM | June 13, 2001 |
| K002761 | fresenius medical care north america | FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS | December 4, 2000 |
| K991908 | idemsa | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS | April 17, 2000 |
| K992594 | althin medical | A-15 HEMODIALYZER | September 24, 1999 |
| K992565 | althin medical | A-18 HEMODIALYZER | September 23, 1999 |
| K991512 | asahi medical co | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | July 29, 1999 |
| K990159 | dynamic technology | DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 | April 19, 1999 |
| K982337 | haidylena medical egypt | CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER | December 29, 1998 |
| K981253 | interpore intl | ULTRACON ULTRAFILTRATOR | December 11, 1998 |
| K980658 | baxter healthcare | PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 | May 19, 1998 |
| K971710 | quantic biomedical | ULTRACON ULTRAFILTRATOR | February 27, 1998 |
| K973291 | dynamic technology | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES | December 19, 1997 |
| K970708 | terumo medical | CLIRANS T-SERIES HOLLOW FIBER DIALYZERS | December 19, 1997 |
| K963933 | baxter healthcare | PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER | November 24, 1997 |
| K962309 | althin medical ab an affiliate of baxter intl | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS | December 27, 1996 |
| K961039 | dayspring medical | BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE V | September 12, 1996 |