K103220 is an FDA 510(k) clearance for the VOYAGER PERITONEAL DIALYSIS SYSTEM. This device is classified as a System, Peritoneal, Automatic Delivery (Class II - Special Controls, product code FKX).
Submitted by Deka Research & Development Corp. (Manchester, US). The FDA issued a Cleared decision on July 29, 2011, 270 days after receiving the submission on November 1, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K103220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2010 |
| Decision Date | July 29, 2011 |
| Days to Decision | 270 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 |