The following data is part of a premarket notification filed by Inari Medical, Inc. with the FDA for Clottriever Thrombectomy System.
| Device ID | K210689 |
| 510k Number | K210689 |
| Device Name: | ClotTriever Thrombectomy System |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| Applicant | Inari Medical, Inc. 9 Parker, Suite 100 Irvine, CA 92618 |
| Contact | Larry Boucher |
| Correspondent | Larry Boucher Inari Medical, Inc. 9 Parker, 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 | 2021-03-08 |
| Decision Date | 2021-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810123710430 | K210689 | 000 |
| 00810123710058 | K210689 | 000 |