Clearance Summary
BASIXCONPAK ANALOG INFLATION SYRINGE received FDA 510(k) clearance under submission number K122321, sponsored by Merit Medical Ireland, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2012-12-19.
- Submission: K122321
- Applicant / Sponsor: Merit Medical Ireland, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2012-12-19
Classification & Regulation
This clearance is catalogued under FDA product code MAV and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.