Clearance Summary
DUROMEDICS CARDIAC VALVE SIZER SET received FDA 510(k) clearance under submission number K853313, sponsored by Hemex Scientific, 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 1985-11-01.
- Submission: K853313
- Applicant / Sponsor: Hemex Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.3945
- Decision date: 1985-11-01
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.