Clearance Summary
GORE Molding and Occlusion Balloon Catheter received FDA 510(k) clearance under submission number K172567, sponsored by W. L. Gore and 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 2018-01-31.
- Submission: K172567
- Applicant / Sponsor: W. L. Gore and Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4450
- Decision date: 2018-01-31
Classification & Regulation
This clearance is catalogued under FDA product code MJN and 21 CFR 870.4450, within the Cardiovascular review panel as a Class II device.