Clearance Summary
TRUE received FDA 510(k) clearance under submission number K993913, sponsored by Infinity Extrusion & 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 2000-08-09.
- Submission: K993913
- Applicant / Sponsor: Infinity Extrusion & Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2000-08-09
Classification & Regulation
This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.