The following data is part of a premarket notification filed by Inari Medical with the FDA for Retraction Aspirator.
| Device ID | K152097 |
| 510k Number | K152097 |
| Device Name: | Retraction Aspirator |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-28 |
| Decision Date | 2015-08-25 |
| Summary: | summary |