Clearance Summary
GORE-TEX TUNNELER received FDA 510(k) clearance under submission number K844584, 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 1985-01-24.
- Submission: K844584
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4500
- Decision date: 1985-01-24
Classification & Regulation
This clearance is catalogued under FDA product code DWS and 21 CFR 870.4500, within the Cardiovascular review panel as a Class I device.