K951247 is an FDA 510(k) clearance for the SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on November 2, 1995, 227 days after receiving the submission on March 20, 1995.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K951247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1995 |
| Decision Date | November 02, 1995 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTZ — Oxygenator, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4350 |