The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Trevo Trak 21 Microcatheter.
Device ID | K211594 |
510k Number | K211594 |
Device Name: | Trevo Trak 21 Microcatheter |
Classification | Catheter, Percutaneous, Neurovasculature |
Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
Contact | Shivani H Patel |
Correspondent | Shivani H Patel Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
Product Code | QJP |
Subsequent Product Code | DQO |
Subsequent Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-24 |
Decision Date | 2021-11-26 |