The following data is part of a premarket notification filed by Inari Medical with the FDA for Apiration Guide Catheter ; Flowtriever Catheter.
| Device ID | K182233 |
| 510k Number | K182233 |
| Device Name: | Apiration Guide Catheter ; FlowTriever Catheter |
| Classification | Catheter, Embolectomy |
| Applicant | Inari Medical 9272 Jeronimo Rd., Suite 124 Irvine, CA 92618 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon Inari Medical 9272 Jeronimo Rd., 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 | 2018-08-17 |
| Decision Date | 2018-10-15 |
| Summary: | summary |