Clearance Summary
FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN received FDA 510(k) clearance under submission number K843500, 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 1984-10-18.
- Submission: K843500
- Applicant / Sponsor: Cardio-Vascular Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1984-10-18
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.