The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Trevo Pro Vue Retriever And Trevo Xp Pro Vue Retriever (trevo Retriever).
| Device ID | K173352 |
| 510k Number | K173352 |
| Device Name: | Trevo Pro Vue Retriever And Trevo XP Pro Vue Retriever (Trevo Retriever) |
| Classification | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Applicant | Concentric Medical, Inc. 301 East Evelyn Avenue Mountain View, CA 94041 |
| Contact | Rhoda M. Santos |
| Correspondent | Rhoda M. Santos Concentric Medical, Inc. 301 East Evelyn Avenue Mountain View, CA 94041 |
| Product Code | POL |
| CFR Regulation Number | 882.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-25 |
| Decision Date | 2018-02-15 |
| Summary: | summary |