The following data is part of a premarket notification filed by Inari Medical with the FDA for Flowsaver Blood Filter.
| Device ID | K210176 |
| 510k Number | K210176 |
| Device Name: | FlowSaver Blood Filter |
| Classification | Apparatus, Autotransfusion |
| Applicant | Inari Medical 9 Parker, Suite 100 Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon Inari Medical 9 Parker, Suite 100 Irvine, CA 92618 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-22 |
| Decision Date | 2021-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850291007246 | K210176 | 000 |