The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Axs Vecta Aspiration Catheter.
Device ID | K190833 |
510k Number | K190833 |
Device Name: | AXS Vecta Aspiration Catheter |
Classification | Catheter, Percutaneous |
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 | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-01 |
Decision Date | 2019-12-15 |