K131935 is an FDA 510(k) clearance for the ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER. This device is classified as a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II - Special Controls, product code KDI).
Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on December 20, 2013, 176 days after receiving the submission on June 27, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K131935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2013 |
| Decision Date | December 20, 2013 |
| Days to Decision | 176 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5860 |