Clearance Summary
GORE FLOW REVERSAL SYSTEM MODEL GFRS073 received FDA 510(k) clearance under submission number K123156, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-12-13.
- Submission: K123156
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2012-12-13
Classification & Regulation
This clearance is catalogued under FDA product code NTE and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.