C-Dak TM 2800 Artificial Kidney
FDA 510(k) K800704 · Cordis Corp.
510(k) numberK800704
Submission
- Device name
- C-Dak TM 2800 Artificial Kidney
- Applicant
- Cordis Corp.
Mchenry, IL, US - Received
- March 31, 1980
- Decision date
- May 8, 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
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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 |
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| K201377 | SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterLIT · Traditional | 10/09/2020SE |
| K201333 | SABER .035 PTA Dilatation CatheterLIT · Traditional | 09/11/2020SE |
| K181592 | RAIN Sheath TransradialDYB · Traditional | 08/15/2018SE |
| K180081 | RAILWAY Sheathless Access SystemDYB · Traditional | 04/18/2018SE |
| K143412 | ADROIT Guiding CatheterDQY · Special | 01/14/2015SE |
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Questions and answers
When was C-Dak TM 2800 Artificial Kidney cleared by the FDA?
C-Dak TM 2800 Artificial Kidney (K800704) received a 510(k) decision of Substantially Equivalent on May 8, 1980, 38 days after the submission was received.
What is the product code of K800704?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.