Clearance Summary
HEART CATHETERIZATION TRAY SET received FDA 510(k) clearance under submission number K840022, sponsored by Medi-Plast Intl., 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 1984-02-04.
- Submission: K840022
- Applicant / Sponsor: Medi-Plast Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1310
- Decision date: 1984-02-04
Classification & Regulation
This clearance is catalogued under FDA product code DRE and 21 CFR 870.1310, within the Cardiovascular review panel as a Class II device.