Clearance Summary
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath received FDA 510(k) clearance under submission number K212165, sponsored by Innovative Health, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-03-10.
- Submission: K212165
- Applicant / Sponsor: Innovative Health, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2022-03-10
Classification & Regulation
This clearance is catalogued under FDA product code PNE and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.