Product code FJI
- Device name
- Dialyzer, Capillary, Hollow Fiber
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190459 | Hemoflow F3 and F4 Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC | 2019-08-23 |
| K122952 | NIPRO PUREFLUX-L HEMODIALYZER | Nipro Medical Corporation | 2013-12-04 |
| K043342 | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR | Gambro Renal Products | 2005-05-27 |
| K010366 | DISPOSABLE STORAGE CAP | Molded Products, Inc. | 2001-11-28 |
| K011148 | ULTRACONCENTRATOR SYSTEM | Interpore Cross Intl. | 2001-06-13 |
| K002761 | FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS | Fresenius Medical Care North America | 2000-12-04 |
| K991908 | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS | Idemsa | 2000-04-17 |
| K992594 | A-15 HEMODIALYZER | Althin Medical AB | 1999-09-24 |
| K992565 | A-18 HEMODIALYZER | Althin Medical AB | 1999-09-23 |
| K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | Asahi Medical Co., Ltd. | 1999-07-29 |
| K990159 | DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 | Dynamic Technology Corp. | 1999-04-19 |
| K982337 | CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER | Haidylena Medical Egypt | 1998-12-29 |
| K981253 | ULTRACON ULTRAFILTRATOR | Interpore Intl. | 1998-12-11 |
| K980658 | PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 | Baxter Healthcare Corp | 1998-05-19 |
| K971710 | ULTRACON ULTRAFILTRATOR | Quantic Biomedical, Inc. | 1998-02-27 |
| K973291 | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES | Dynamic Technology Corp. | 1997-12-19 |
| K970708 | CLIRANS T-SERIES HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | 1997-12-19 |
| K963933 | PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER | Baxter Healthcare Corp | 1997-11-24 |
| K962309 | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS | Althin Medical AB an Affiliate of Baxter Intl | 1996-12-27 |
| K961039 | BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL | Dayspring Medical, Inc. | 1996-09-12 |
| K961040 | BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC | Dayspring Medical, Inc. | 1996-06-11 |
| K961026 | BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL | Dayspring Medical, Inc. | 1996-06-10 |
| K944436 | COBE CENTRYSYSTEM CS 200 DIALYZER | Cobe Renal Care, Inc. | 1996-01-29 |
| K952343 | FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER | National Medical Care, Medical Products Div., Inc. | 1995-12-22 |
| K950602 | PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS | Reprocessing Products Corp | 1995-11-30 |
| K945746 | GAMBRO LUNDIA 94-500 DIALYZER | Cobe Renal Care, Inc. | 1995-09-08 |
| K945622 | MCA(TM) 180 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-25 |
| K935471 | FILTRYZER(TM) | Toray Industries (America), Inc. | 1995-05-19 |
| K945623 | MCA(TM) 130 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 |
| K945624 | MCA(TM) 160 HEMODIALYZER | Althin Medical AB an Affiliate of Baxter Intl | 1995-05-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B144MPC40S0 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2022-08-04 |
| B144MPC451 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC50DV1 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC50DVY1 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC60B1 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC60D1 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC60DR1 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| B144MPC401 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2019-09-04 |
| 00858293006366 | Dialysate Port Cap - E-Z Grip® Twist Lock - Rigid | REPROCESSING PRODUCTS CORPORATION | 2019-08-27 |
| 00858293006311 | Blood Port Caps - E-ZGrip, Rigid, Twist Lock | REPROCESSING PRODUCTS CORPORATION | 2019-08-27 |
| 00858293006304 | Blood Port Caps Twist Lock ISO Bulk | REPROCESSING PRODUCTS CORPORATION | 2019-08-27 |
| 00858293006298 | Blood Port Caps Twist Lock ISO | REPROCESSING PRODUCTS CORPORATION | 2019-08-27 |
| 00858293006236 | "Dialysate Port Cap 1""" | REPROCESSING PRODUCTS CORPORATION | 2019-08-26 |
| 00858293006274 | Auto-Vent Port Caps | REPROCESSING PRODUCTS CORPORATION | 2019-08-26 |
| 00858293006267 | Blood Port Caps Bulk | REPROCESSING PRODUCTS CORPORATION | 2019-08-26 |
| 00858293006250 | Blood Port Caps | REPROCESSING PRODUCTS CORPORATION | 2019-08-26 |
| 00858293006243 | "Dialysate POrt Caps 1"" Bulk" | REPROCESSING PRODUCTS CORPORATION | 2019-08-26 |
| 00858293006229 | "Dialysate Port Caps 1.5"" Bulk" | REPROCESSING PRODUCTS CORPORATION | 2019-08-26 |
| 00858293006212 | "Dialysate Port Caps 1.5""" | REPROCESSING PRODUCTS CORPORATION | 2019-08-26 |
| 07332414031770 | POLYFLUX | Gambro Dialysatoren GmbH | 2015-10-12 |
| 00840861100149 | Optiflux® | Fresenius Medical Care Holdings, Inc. | 2015-09-24 |
| 00840861100040 | Hemoflow™ | Fresenius Medical Care Holdings, Inc. | 2015-09-24 |
| 00840861100033 | Hemoflow™ | Fresenius Medical Care Holdings, Inc. | 2015-09-24 |
| 00840861100026 | Hemoflow™ | Fresenius Medical Care Holdings, Inc. | 2015-09-24 |
| 00840861100019 | Hemoflow™ | Fresenius Medical Care Holdings, Inc. | 2015-09-24 |
| 04046964319891 | Diacap® | B.Braun Avitum AG | 2015-08-09 |
| 04046964319969 | Diacap® | B.Braun Avitum AG | 2015-08-09 |
| 04046964319983 | Diacap® | B.Braun Avitum AG | 2015-08-09 |
| 04046964320026 | Diacap® | B.Braun Avitum AG | 2015-08-09 |
| 04046964320040 | Diacap® | B.Braun Avitum AG | 2015-08-09 |