Clearance Summary
VICOR, MODEL 410A received FDA 510(k) clearance under submission number K873202, sponsored by Tpl-Cordis, 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 1987-10-15.
- Submission: K873202
- Applicant / Sponsor: Tpl-Cordis, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3610
- Decision date: 1987-10-15
Classification & Regulation
This clearance is catalogued under FDA product code DXY and 21 CFR 870.3610, within the Cardiovascular review panel as a Class III device.