Clearance Summary
DISPOSABLE OPTICAL VALVULOTOME received FDA 510(k) clearance under submission number K914457, sponsored by Nobles-Lai Engineering, 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 1992-02-05.
- Submission: K914457
- Applicant / Sponsor: Nobles-Lai Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4885
- Decision date: 1992-02-05
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.