Clearance Summary
ScleroSafe 150 mm, ScleroSafe 350 mm received FDA 510(k) clearance under submission number K231148, sponsored by Vvt 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 2023-06-20.
- Submission: K231148
- Applicant / Sponsor: Vvt Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1210
- Decision date: 2023-06-20
Classification & Regulation
This clearance is catalogued under FDA product code KRA and 21 CFR 870.1210, within the Cardiovascular review panel as a Class II device.