Clearance Summary
PULSE*SPRAY INFUSION SYSTEM received FDA 510(k) clearance under submission number K950907, sponsored by Angiodynamics, Div. 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 1995-05-17.
- Submission: K950907
- Applicant / Sponsor: Angiodynamics, Div. E-Z-Em, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5150
- Decision date: 1995-05-17
Classification & Regulation
This clearance is catalogued under FDA product code QEY and 21 CFR 870.5150, within the Cardiovascular review panel as a Class II device.