The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Trevo Xp Provue Retriever (6x25mm).
| Device ID | K143077 |
| 510k Number | K143077 |
| Device Name: | Trevo XP ProVue Retriever (6X25mm) |
| Classification | Catheter, Thrombus Retriever |
| Applicant | CONCENTRIC MEDICAL, INC. 301 EAST EVELYN AVENUE Mountain View, CA 94041 |
| Contact | Bill Hyatt |
| Correspondent | Bill Hyatt 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 | 2014-10-27 |
| Decision Date | 2015-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815742001860 | K143077 | 000 |