Clearance Summary
VasQ received FDA 510(k) clearance under submission number K240119, sponsored by Laminate Medical Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-02-16.
- Submission: K240119
- Applicant / Sponsor: Laminate Medical Technologies , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4600
- Decision date: 2024-02-16
Classification & Regulation
This clearance is catalogued under FDA product code QVQ and 21 CFR 870.4600, within the Cardiovascular review panel as a Class II device.