K070512 is an FDA 510(k) clearance for the MODIFICATION TO AQUADEX FLEXFLOW SYSTEM. This device is classified as a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II - Special Controls, product code KDI).
Submitted by Chf Solutions, Inc. (Brooklyn Park Mn, US). The FDA issued a Cleared decision on April 27, 2007, 64 days after receiving the submission on February 22, 2007.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K070512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 2007 |
| Decision Date | April 27, 2007 |
| Days to Decision | 64 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 |