Clearance Summary
VASSALLO GT 018 G12; VASSALLO GT 018 G30 received FDA 510(k) clearance under submission number K232578, sponsored by Filmec Co. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-10-11.
- Submission: K232578
- Applicant / Sponsor: Filmec Co. , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2023-10-11
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.