Clearance Summary
Merit MAK Nitinol/Gold-Tungsten Guide Wire received FDA 510(k) clearance under submission number K261640, sponsored by Merit Medical Ireland , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-07-13.
- Submission: K261640
- Applicant / Sponsor: Merit Medical Ireland , Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2026-07-13
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.