K231782 is an FDA 510(k) clearance for the FlowSaver Blood Return System (80-101). This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).
Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on July 14, 2023, 28 days after receiving the submission on June 16, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K231782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2023 |
| Decision Date | July 14, 2023 |
| Days to Decision | 28 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 |