Clearance Summary
ASTRO TRACE (MODEL AT-02) received FDA 510(k) clearance under submission number K885137, sponsored by The LE Blanc Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1989-03-15.
- Submission: K885137
- Applicant / Sponsor: The LE Blanc Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 1989-03-15
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.