The following data is part of a premarket notification filed by Inari Medical, Inc. with the FDA for Flowtriever Retrieval/aspiration System, Flowtriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24.
| Device ID | K211013 |
| 510k Number | K211013 |
| Device Name: | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-05 |
| Decision Date | 2021-04-30 |