Clearance Summary
AXS Infinity LS Plus Long Sheath received FDA 510(k) clearance under submission number K193034, sponsored by Stryker Neurovascular. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-11-29.
- Submission: K193034
- Applicant / Sponsor: Stryker Neurovascular
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2019-11-29
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.