Clearance Summary
CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. received FDA 510(k) clearance under submission number K863917, sponsored by Cardio-Vascular Innovations, 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 1987-01-06.
- Submission: K863917
- Applicant / Sponsor: Cardio-Vascular Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1987-01-06
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.