The following data is part of a premarket notification filed by Inari Medical with the FDA for Artix Thrombectomy Device.
| Device ID | K220600 |
| 510k Number | K220600 |
| Device Name: | Artix Thrombectomy Device |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-02 |
| Decision Date | 2022-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850291007345 | K220600 | 000 |