K011221 is an FDA 510(k) clearance for the PRISMA HF 1000 SET, PRISMA HF 1000 PRE-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 October 31, 2001, 194 days after receiving the submission on April 20, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K011221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 2001 |
| Decision Date | October 31, 2001 |
| Days to Decision | 194 days |
| Submission Type | Traditional |
| 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 |