The following data is part of a premarket notification filed by Stryker with the FDA for Trevo Xp Provue Retriever.
Device ID | K190779 |
510k Number | K190779 |
Device Name: | Trevo XP ProVue Retriever |
Classification | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
Applicant | Stryker 47900 Bayside Parkway Fremont, CA 94538 |
Contact | Rhoda M. Santos |
Correspondent | Rhoda M. Santos Stryker 47900 Bayside Parkway Fremont, CA 94538 |
Product Code | POL |
CFR Regulation Number | 882.5600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-03-27 |
Decision Date | 2019-06-25 |