K050273 is an FDA 510(k) clearance for the FRESENIUS ART HEMOADSORPTION SYSTEM. This device is classified as a Separator, Automated, Blood Cell And Plasma, Therapeutic.
Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on June 8, 2005, 121 days after receiving the submission on February 7, 2005.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K050273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2005 |
| Decision Date | June 08, 2005 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |