K061515 is an FDA 510(k) clearance for the RENALSOFT. This device is classified as a System, Dialysate Delivery, Semi-automatic, Peritoneal (Class II - Special Controls, product code KPF).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on September 11, 2006, 102 days after receiving the submission on June 1, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K061515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2006 |
| Decision Date | September 11, 2006 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPF — System, Dialysate Delivery, Semi-automatic, Peritoneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5630 |