Clearance Summary
IVR-SP CUSTOM ANGIOGRAPHY TRAY received FDA 510(k) clearance under submission number K870419, sponsored by North Coast Medi-Tek. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1987-05-11.
- Submission: K870419
- Applicant / Sponsor: North Coast Medi-Tek
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 1987-05-11
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.