K970662 is an FDA 510(k) clearance for the CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210), a Hemodialyzer, Re-use, High Flux (Class II — Special Controls, product code MSF), submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on March 11, 1998, 383 days after receiving the submission on February 21, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.
| 510(k) Number | K970662 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 21, 1997 |
| Decision Date | March 11, 1998 |
| Days to Decision | 383 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 |