The following data is part of a premarket notification filed by Inari Medical with the FDA for Flowtriever Retrieval/aspiration System.
| Device ID | K191710 |
| 510k Number | K191710 |
| Device Name: | FlowTriever Retrieval/Aspiration System |
| Classification | Peripheral Mechanical Thrombectomy With Aspiration |
| 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 | QEW |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-26 |
| Decision Date | 2019-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850291007185 | K191710 | 000 |