Clearance Summary
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) received FDA 510(k) clearance under submission number K190282, sponsored by Spectrum Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-05-24.
- Submission: K190282
- Applicant / Sponsor: Spectrum Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4220
- Decision date: 2019-05-24
Classification & Regulation
This clearance is catalogued under FDA product code DTQ and 21 CFR 870.4220, within the Cardiovascular review panel as a Class II device.