Clearance Summary
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle received FDA 510(k) clearance under submission number K152913, sponsored by Creganna Medical Aslo Business AS Cregganna Tactx Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-07-21.
- Submission: K152913
- Applicant / Sponsor: Creganna Medical Aslo Business AS Cregganna Tactx Medical
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 2016-07-21
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.