K192122 is an FDA 510(k) clearance for the Trevo Trak 21 Microcatheter. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by Stryker (Fremont, US). The FDA issued a Cleared decision on November 22, 2019, 108 days after receiving the submission on August 6, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K192122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2019 |
| Decision Date | November 22, 2019 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |