The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Axs Vecta 71 Intermediate Catheter, Axs Vecta 74 Intermediate Catheter.
Device ID | K200206 |
510k Number | K200206 |
Device Name: | AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter |
Classification | Catheter, Percutaneous, Neurovasculature |
Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
Contact | Shazia Hakim |
Correspondent | Shazia Hakim Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
Product Code | QJP |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-01-28 |
Decision Date | 2020-02-27 |