K982413 is an FDA 510(k) clearance for the COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS. 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 Healthcare (Lakewood, US). The FDA issued a Cleared decision on April 21, 1999, 282 days after receiving the submission on July 13, 1998.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K982413 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 13, 1998 |
| Decision Date | April 21, 1999 |
| Days to Decision | 282 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 |