The following data is part of a premarket notification filed by Stryker with the FDA for Trevo Nxt Provue Retriever.
| Device ID | K192207 |
| 510k Number | K192207 |
| 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 | 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 | 2019-08-14 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327299953 | K192207 | 000 |
| 07613327299946 | K192207 | 000 |
| 07613327299939 | K192207 | 000 |
| 07613327299922 | K192207 | 000 |