The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Sofia Plus Aspiration Catheter.
| Device ID | K173200 |
| 510k Number | K173200 |
| Device Name: | SOFIA Plus Aspiration Catheter |
| Classification | Catheter, Thrombus Retriever |
| Applicant | MicroVention, Inc. 1311 Valencia Avenue Tustin, CA 92780 |
| Contact | Naomi Gong |
| Correspondent | Naomi Gong MicroVention, Inc. 1311 Valencia Avenue Tustin, CA 92780 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-06-11 |
| Summary: | summary |