K111702 is an FDA 510(k) clearance for the AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE, a Separator, Automated, Blood Cell And Plasma, Therapeutic, submitted by Fenwal, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on March 22, 2012, 279 days after receiving the submission on June 17, 2011. This device falls under the Gastroenterology & Urology review panel.
| 510(k) Number | K111702 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 2011 |
| Decision Date | March 22, 2012 |
| Days to Decision | 279 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LKN — Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Device Class | — |