K023874 is an FDA 510(k) clearance for the SYSTEM 100 ULTRAFILTRATION CATHETER. 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, US). The FDA issued a Cleared decision on November 20, 2003, 364 days after receiving the submission on November 21, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K023874 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2002 |
| Decision Date | November 20, 2003 |
| Days to Decision | 364 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 |