Clearance Summary
HEPARIN COATED BALLOON THERMODILU received FDA 510(k) clearance under submission number K834037, sponsored by Nova Medical Specialties. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1984-01-10.
- Submission: K834037
- Applicant / Sponsor: Nova Medical Specialties
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1240
- Decision date: 1984-01-10
Classification & Regulation
This clearance is catalogued under FDA product code DYG and 21 CFR 870.1240, within the Cardiovascular review panel as a Class II device.