The following data is part of a premarket notification filed by Inari Medical with the FDA for Flowtriever Catheter, 6-10 Mm; Flowtreiver Catheter, 11-14 Mm; Flowtreiver Catheter, 15-18 Mm; Aspiration Guide Catheter; Retraction Aspirator.
| Device ID | K180466 |
| 510k Number | K180466 |
| Device Name: | FlowTriever Catheter, 6-10 Mm; FlowTreiver Catheter, 11-14 Mm; FlowTreiver Catheter, 15-18 Mm; Aspiration Guide Catheter; Retraction Aspirator |
| Classification | Catheter, Embolectomy |
| Applicant | Inari Medical 9272 Jeronimo Road Suite 124 Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon Inari Medical 9272 Jeronimo Road Suite 124 Irvine, CA 92618 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-21 |
| Decision Date | 2018-05-17 |
| Summary: | summary |