The following data is part of a premarket notification filed by Stryker with the FDA for Trevo Nxt Provue Retriever.
Device ID | K200117 |
510k Number | K200117 |
Device Name: | Trevo NXT ProVue Retriever |
Classification | Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment |
Applicant | Stryker 47900 Bayside Parkway Fremont, CA 94538 |
Contact | Germaine Fu |
Correspondent | Germaine Fu Stryker 47900 Bayside Parkway Fremont, CA 94538 |
Product Code | POL |
CFR Regulation Number | 882.5600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-01-21 |
Decision Date | 2020-02-07 |