Clearance Summary
FOGARTY VALVULOTOME MODEL 700091 received FDA 510(k) clearance under submission number K965137, sponsored by Baxter Edwards. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1997-06-04.
- Submission: K965137
- Applicant / Sponsor: Baxter Edwards
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4885
- Decision date: 1997-06-04
Classification & Regulation
This clearance is catalogued under FDA product code MGZ and 21 CFR 870.4885, within the Cardiovascular review panel as a Class II device.