Clearance Summary
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH received FDA 510(k) clearance under submission number K854113, 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 1986-01-08.
- Submission: K854113
- Applicant / Sponsor: American Bentley
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.4200
- Decision date: 1986-01-08
Classification & Regulation
This clearance is catalogued under FDA product code KRI and 21 CFR 870.4200, within the Cardiovascular review panel as a Class I device.