K070643 is an FDA 510(k) clearance for the PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Gambro, Inc. (Lakewood, US). The FDA issued a Cleared decision on November 2, 2007, 239 days after receiving the submission on March 8, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K070643 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 08, 2007 |
| Decision Date | November 02, 2007 |
| Days to Decision | 239 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 |