Clearance Summary
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) received FDA 510(k) clearance under submission number K240908, 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 2025-07-08.
- Submission: K240908
- Applicant / Sponsor: Spectrum Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4240
- Decision date: 2025-07-08
Classification & Regulation
This clearance is catalogued under FDA product code DTR and 21 CFR 870.4240, within the Cardiovascular review panel as a Class II device.