Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber Dialyzer
FDA 510(k) K952343 · National Medical Care, Medical Products Div., Inc.
510(k) numberK952343
Submission
- Device name
- Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber Dialyzer
- Applicant
- National Medical Care, Medical Products Div., Inc.
Rockleigh, NJ, US - Received
- May 19, 1995
- Decision date
- December 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
| 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 |
| K915628 | Dextrolyte II Peritoneal Dialysis PumpKDJ · Traditional | 03/16/1992SE |
Questions and answers
When was Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber Dialyzer cleared by the FDA?
Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber Dialyzer (K952343) received a 510(k) decision of Substantially Equivalent on December 22, 1995, 217 days after the submission was received.
What is the product code of K952343?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.