Clirans TH13 Hollow Fiber Dialyzer
FDA 510(k) K802122 · Terumo America, Inc.
510(k) numberK802122
Submission
- Device name
- Clirans TH13 Hollow Fiber Dialyzer
- Applicant
- Terumo America, Inc.
Mchenry, IL, US - Received
- September 4, 1980
- Decision date
- December 18, 1980
- 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 |
|---|---|---|
| K811523 | Plasma FlexKSR · Traditional | 09/09/1981SE |
| K802970 | Terumo Hollow Fiber OxygenatorDTZ · Traditional | 01/22/1981SE |
| K802441 | Clirans TH10 Hollow Fiber DialyzerFJI · Traditional | 12/18/1980SE |
| K801194 | Clirans TE07 Hollow Fiber DialyzerFJI · Traditional | 08/12/1980SE |
| K801193 | Clirans TE15 Hollow Fiber DialyzerKDJ · Traditional | 08/12/1980SE |
| K801192 | Clirans TE10 Hollow Fiber DialyzerFJI · Traditional | 08/12/1980SE |
| K791411 | Coaxial Dual Flow CatheterKOC · Traditional | 11/13/1979SE |
| K791173 | Surflo Injection PlugFPA · Traditional | 07/30/1979SE |
| K790105 | Terumo ImugardGKT · Traditional | 05/24/1979SE |
| K772362 | Avf Set for Single Needle HemodialysisFIE · Traditional | 03/17/1978SE |
Questions and answers
When was Clirans TH13 Hollow Fiber Dialyzer cleared by the FDA?
Clirans TH13 Hollow Fiber Dialyzer (K802122) received a 510(k) decision of Substantially Equivalent on December 18, 1980, 105 days after the submission was received.
What is the product code of K802122?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.