Clearance Summary
EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 received FDA 510(k) clearance under submission number K031571, sponsored by E-Z-Em, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-06-19.
- Submission: K031571
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2003-06-19
Classification & Regulation
This clearance is catalogued under FDA product code IZQ and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.