K002892 is an FDA 510(k) clearance for the FRSENIUS PD IQCARD CYCLER. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Fresenius Medical Care North America (Lexington, US). The FDA issued a Cleared decision on April 5, 2001, 202 days after receiving the submission on September 15, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K002892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2000 |
| Decision Date | April 05, 2001 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FKX — System, Peritoneal, Automatic Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |