Clirans Hollow Fiber Hemodialyzer (Wet)
FDA 510(k) K891477 · Terumo Medical Corp.
510(k) numberK891477
Submission
- Device name
- Clirans Hollow Fiber Hemodialyzer (Wet)
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- March 16, 1989
- Decision date
- June 9, 1989
- 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
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| K043342 | Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional | Gambro Renal Products | 05/27/2005SE |
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| 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 |
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Questions and answers
When was Clirans Hollow Fiber Hemodialyzer (Wet) cleared by the FDA?
Clirans Hollow Fiber Hemodialyzer (Wet) (K891477) received a 510(k) decision of Substantially Equivalent on June 9, 1989, 85 days after the submission was received.
What is the product code of K891477?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.