Clearance Summary
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS received FDA 510(k) clearance under submission number K864155, sponsored by American Edwards Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1986-11-20.
- Submission: K864155
- Applicant / Sponsor: American Edwards Laboratories
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.3935
- Decision date: 1986-11-20
Classification & Regulation
This clearance is catalogued under FDA product code DTJ and 21 CFR 870.3935, within the Cardiovascular review panel as a Class I device.