The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Trevo Xp Provue Retriever (4x30mm).
| Device ID | K150616 |
| 510k Number | K150616 |
| Device Name: | Trevo XP ProVue Retriever (4x30mm) |
| Classification | Catheter, Thrombus Retriever |
| 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 | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-10 |
| Decision Date | 2015-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815742001853 | K150616 | 000 |