K163530 is an FDA 510(k) clearance for the PrisMax Control Unit, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Baxter Healthcare Corp (Brooklyn Park Mn, US). The FDA issued a Cleared decision on May 3, 2017, 138 days after receiving the submission on December 16, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K163530 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 16, 2016 |
| Decision Date | May 03, 2017 |
| Days to Decision | 138 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 |