The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Axs Vecta Aspiration System.
| Device ID | K191768 |
| 510k Number | K191768 |
| Device Name: | AXS Vecta Aspiration System |
| Classification | Catheter, Thrombus Retriever |
| 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 | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-01 |
| Decision Date | 2019-07-30 |
| Summary: | summary |