Clearance Summary
MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMP received FDA 510(k) clearance under submission number K903494, sponsored by Life-Tech Intl., 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 1990-10-17.
- Submission: K903494
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 1990-10-17
Classification & Regulation
This clearance is catalogued under FDA product code DXT and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.