Clearance Summary
Spartan MC 0165 received FDA 510(k) clearance under submission number K213451, sponsored by Spartan Micro. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-11-22.
- Submission: K213451
- Applicant / Sponsor: Spartan Micro
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2021-11-22
Classification & Regulation
This clearance is catalogued under FDA product code QJP and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.