Clearance Summary
GORE® ACUSEAL Vascular Graft received FDA 510(k) clearance under submission number K233551, sponsored by W. L. Gore & Associates, 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 2023-12-19.
- Submission: K233551
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3450
- Decision date: 2023-12-19
Classification & Regulation
This clearance is catalogued under FDA product code DSY and 21 CFR 870.3450, within the Cardiovascular review panel as a Class II device.