The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Axs Vecta 46 Intermediate Catheter.
Device ID | K202752 |
510k Number | K202752 |
Device Name: | AXS Vecta 46 Intermediate Catheter |
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 |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-21 |
Decision Date | 2021-08-27 |