K910568 is an FDA 510(k) clearance for the MODEL 5866-46 SLEEVE KIT. This device is classified as a Defoamer, Cardiopulmonary Bypass (Class II - Special Controls, product code DTP).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on April 9, 1991, 57 days after receiving the submission on February 11, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4230.
| 510(k) Number | K910568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1991 |
| Decision Date | April 09, 1991 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTP — Defoamer, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4230 |