FJI — Dialyzer, Capillary, Hollow Fiber Class II
FDA product code FJI covers "Dialyzer, Capillary, Hollow Fiber", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
| K970708 | terumo medical | CLIRANS T-SERIES HOLLOW FIBER DIALYZERS | December 19, 1997 |
| K973291 | dynamic technology | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES | 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 |