The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Axs Infinity Ls Plus Long Sheath.
| Device ID | K193034 |
| 510k Number | K193034 |
| Device Name: | AXS Infinity LS Plus Long Sheath |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-31 |
| Decision Date | 2019-11-29 |
| Summary: | summary |