K001156 is an FDA 510(k) clearance for the PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET. This device is classified as a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI).
Submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on July 7, 2000, 88 days after receiving the submission on April 10, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K001156 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2000 |
| Decision Date | July 07, 2000 |
| Days to Decision | 88 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5860 |