K895356 is an FDA 510(k) clearance for the UNIVOX-IC. This device is classified as a Reservoir, Blood, Cardiopulmonary Bypass (Class II - Special Controls, product code DTN).
Submitted by Baxter Healthcare Corp (Irvine, US). The FDA issued a Cleared decision on March 6, 1990, 190 days after receiving the submission on August 28, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K895356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1989 |
| Decision Date | March 06, 1990 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |