K970679 is an FDA 510(k) clearance for the ALTRA FLUX 200 HEMODIALYZER, a Hemodialyzer, Re-use, High Flux (Class II — Special Controls, product code MSF), submitted by Althin Medical AB an Affiliate of Baxter Intl (Miami Lakes, US). The FDA issued a Cleared decision on July 23, 1998, 514 days after receiving the submission on February 24, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K970679 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 1997 |
| Decision Date | July 23, 1998 |
| Days to Decision | 514 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MSF — Hemodialyzer, Re-use, High Flux |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5860 |