Clearance Summary
GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE received FDA 510(k) clearance under submission number K851080, sponsored by G V Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-06-20.
- Submission: K851080
- Applicant / Sponsor: G V Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 1985-06-20
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.