Hollow Fiber Dialyzer Focus 70,90,120,90H,120H
FDA 510(k) K871236 · National Medical Care, Medical Products Div., Inc.
510(k) numberK871236
Submission
- Device name
- Hollow Fiber Dialyzer Focus 70,90,120,90H,120H
- Applicant
- National Medical Care, Medical Products Div., Inc.
Rockleigh, NJ, US - Received
- March 27, 1987
- Decision date
- May 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJI – Dialyzer, Capillary, Hollow Fiber
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190459 | Hemoflow F3 and F4 DialyzersFJI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/23/2019SE |
| K122952 | Nipro Pureflux-L HemodialyzerFJI · Traditional | Nipro Medical Corporation | 12/04/2013SE |
| K043342 | Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional | Gambro Renal Products | 05/27/2005SE |
| K010366 | Disposable Storage CapFJI · Abbreviated | Molded Products, Inc. | 11/28/2001SE |
| K011148 | Ultraconcentrator SystemFJI · Special | Interpore Cross Intl. | 06/13/2001SE |
| K002761 | Fresnius Hemoflow F7NR, F50NR, F70NR HemodialyzersFJI · Traditional | Fresenius Medical Care North America | 12/04/2000SE |
| K991908 | Idemsa Hemophan Hollow Fiber DialyzersFJI · Traditional | Idemsa | 04/17/2000SE |
| K992594 | A-15 HemodialyzerFJI · Traditional | Althin Medical AB | 09/24/1999SE |
| K992565 | A-18 HemodialyzerFJI · Traditional | Althin Medical AB | 09/23/1999SE |
| K991512 | Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional | Asahi Medical Co., Ltd. | 07/29/1999SE |
More from Asahi Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K962081 | Combilines Hemodialysis Blood Tubing SetFJK · Traditional | 11/01/1996SE |
| K941757 | Formalin Reuse CartLIF · Traditional | 01/22/1996SE |
| K952343 | Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber DialyzerFJI · Traditional | 12/22/1995SE |
| K930843 | Rapid Disconnect Y-Set, Cat. No. 48-7000KDJ · Traditional | 08/31/1994SE |
| K914790 | Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-RFJI · Traditional | 03/05/1993SE |
| K920797 | Hemodialysis Blood Tubing SetFJK · Traditional | 09/21/1992SE |
| K920697 | Dextrolyte II Peritoneal Dialysis 48-3029-7 ClampFJH · Traditional | 09/21/1992SE |
| K920693 | Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional | 09/21/1992SE |
| K920586 | Dextrolyte II Peritoneal Dialysis Admin. SetKDJ · Traditional | 09/21/1992SE |
| K920029 | Dextrolyte II Capd Trnsfer SetKDJ · Traditional | 09/21/1992SE |
Questions and answers
When was Hollow Fiber Dialyzer Focus 70,90,120,90H,120H cleared by the FDA?
Hollow Fiber Dialyzer Focus 70,90,120,90H,120H (K871236) received a 510(k) decision of Substantially Equivalent on May 29, 1987, 63 days after the submission was received.
What is the product code of K871236?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.