The following data is part of a premarket notification filed by Inari Medical with the FDA for Mini-clottriever Thrombectomy System.
| Device ID | K220887 |
| 510k Number | K220887 |
| Device Name: | Mini-ClotTriever Thrombectomy System |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Inari Medical 6001 Oak Canyon, Suite 100 Irvine, CA 92618 |
| Contact | Ellen Nguyen |
| Correspondent | Ellen Nguyen Inari Medical 6001 Oak Canyon, Suite 100 Irvine, CA 92618 |
| Product Code | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-28 |
| Decision Date | 2022-08-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850291007369 | K220887 | 000 |