Clearance Summary
TRANSPARENT MANIFOLD received FDA 510(k) clearance under submission number K772299, sponsored by Uni-Research. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1977-12-21.
- Submission: K772299
- Applicant / Sponsor: Uni-Research
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4290
- Decision date: 1977-12-21
Classification & Regulation
This clearance is catalogued under FDA product code DTL and 21 CFR 870.4290, within the Cardiovascular review panel as a Class II device.