Clearance Summary
Sapphire NC Plus Coronary Dilatation Catheter received FDA 510(k) clearance under submission number K192344, sponsored by Orbusneich Medical Trading, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-09-19.
- Submission: K192344
- Applicant / Sponsor: Orbusneich Medical Trading, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5100
- Decision date: 2019-09-19
Classification & Regulation
This clearance is catalogued under FDA product code LOX and 21 CFR 870.5100, within the Cardiovascular review panel as a Class II device.