The following data is part of a premarket notification filed by Stryker with the FDA for Trevo Trak 21 Microcatheter.
| Device ID | K192122 |
| 510k Number | K192122 |
| Device Name: | Trevo Trak 21 Microcatheter |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Stryker 47900 Bayside Parkway Fremont, CA 94538 |
| Contact | Rhoda Santos |
| Correspondent | Rhoda Santos Stryker 47900 Bayside Parkway Fremont, CA 94538 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-06 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327313956 | K192122 | 000 |