The following data is part of a De Novo classification by Concentric Medical, Inc. with the FDA for Modified Trevo Provue Retriever, Trevo Xp Provue Retriever 4x20mm, Trevo Xp Provue Retriever 3x20mm, Trevo Xp Provue Retriever 6x25mm, Trevo Xp Provue Retriever 4x30mm.
| DeNovo ID | DEN150049 |
| Device Name: | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm |
| Classification | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
| Applicant | CONCENTRIC MEDICAL, INC. 301 East Evelyn Avenue Mountain View, CA 94041 |
| Contact | Jim Leathley |
| Product Code | POL |
| CFR Regulation Number | 882.5600 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2015-10-26 |
| Decision Date | 2016-09-02 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |