K221491 is an FDA 510(k) clearance for the Anivia SG1000 Pump Console. This device is classified as a Control, Pump Speed, Cardiopulmonary Bypass (Class II - Special Controls, product code DWA).
Submitted by Apmtd, Inc. (Wilmington, US). The FDA issued a Cleared decision on February 3, 2023, 256 days after receiving the submission on May 23, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4380.
| 510(k) Number | K221491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2022 |
| Decision Date | February 03, 2023 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWA - Control, Pump Speed, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4380 |