Clearance Summary
PERCUPUMP II WITH EDA received FDA 510(k) clearance under submission number K974621, sponsored by E-Z-Em, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-01-27.
- Submission: K974621
- Applicant / Sponsor: E-Z-Em, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 1998-01-27
Classification & Regulation
This clearance is catalogued under FDA product code DSB and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.