K210089 is an FDA 510(k) clearance for the CATSmart, Automated Blood Processing Autotransfusion System. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on February 11, 2021, 29 days after receiving the submission on January 13, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K210089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2021 |
| Decision Date | February 11, 2021 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | CAC - Apparatus, Autotransfusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5830 |