Clearance Summary
Drakon and Sequre® Microcatheters received FDA 510(k) clearance under submission number K231293, sponsored by Accurate Medical Therapeutics. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2023-06-01.
- Submission: K231293
- Applicant / Sponsor: Accurate Medical Therapeutics
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2023-06-01
Classification & Regulation
This clearance is catalogued under FDA product code DQO and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.