Idemsa Hemophan Hollow Fiber Dialyzers
FDA 510(k) K991908 · Idemsa
510(k) numberK991908
Submission
- Device name
- Idemsa Hemophan Hollow Fiber Dialyzers
- Applicant
- Idemsa
Westbury, NY, US - Received
- June 7, 1999
- Decision date
- April 17, 2000
- 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
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 |
| 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 |
| K990159 | Dynamic Hollow Fiber Dialyzer Dh-Series, Model Ah 90111FJI · Traditional | Dynamic Technology Corp. | 04/19/1999SE |
Questions and answers
When was Idemsa Hemophan Hollow Fiber Dialyzers cleared by the FDA?
Idemsa Hemophan Hollow Fiber Dialyzers (K991908) received a 510(k) decision of Substantially Equivalent on April 17, 2000, 315 days after the submission was received.
What is the product code of K991908?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.