K122343 is an FDA 510(k) clearance for the PUREFLUX-H HEMODIALYZER, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Nipro Medical Corporation (Suwanee, US). The FDA issued a Cleared decision on May 7, 2013, 277 days after receiving the submission on August 3, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K122343 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 03, 2012 |
| Decision Date | May 07, 2013 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| 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 |