Clearance Summary
CARDIOPLEGIA HEAT EXCHANGER HE-100 received FDA 510(k) clearance under submission number K840045, sponsored by American Bentley. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1984-02-13.
- Submission: K840045
- Applicant / Sponsor: American Bentley
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4240
- Decision date: 1984-02-13
Classification & Regulation
This clearance is catalogued under FDA product code DTR and 21 CFR 870.4240, within the Cardiovascular review panel as a Class II device.