K210176 is an FDA 510(k) clearance for the FlowSaver Blood Filter. This device is classified as a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC).
Submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on July 22, 2021, 181 days after receiving the submission on January 22, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 868.5830.
| 510(k) Number | K210176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 2021 |
| Decision Date | July 22, 2021 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | CAC — Apparatus, Autotransfusion |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5830 |