Clearance Summary
Stent Positioning Assistance System (SPAS) received FDA 510(k) clearance under submission number K221917, sponsored by Seven Sons , 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 2022-08-19.
- Submission: K221917
- Applicant / Sponsor: Seven Sons , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2022-08-19
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.