Clearance Summary
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET received FDA 510(k) clearance under submission number K881279, sponsored by Baxter Healthcare Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-05-18.
- Submission: K881279
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.3945
- Decision date: 1988-05-18
Classification & Regulation
This clearance is catalogued under FDA product code DTI and 21 CFR 870.3945, within the Cardiovascular review panel as a Class I device.