The following data is part of a premarket notification filed by Inari Medical, Inc. with the FDA for Clottriever Thrombectomy System.
| Device ID | K163549 |
| 510k Number | K163549 |
| Device Name: | ClotTriever Thrombectomy System |
| Classification | Catheter, Embolectomy |
| Applicant | Inari Medical, Inc. 9272 Jeronimo Road Suite 124 Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-12-16 |
| Decision Date | 2017-02-16 |
| Summary: | summary |