Clearance Summary
METRONIC MODEL F7700 HEART VALVE SIZERS received FDA 510(k) clearance under submission number K852612, sponsored by Medtronic Vascular. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-09-23.
- Submission: K852612
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class I
- Regulation citation: 21 CFR 870.3945
- Decision date: 1985-09-23
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.