Clearance Summary
HEARTLINK, MODEL II received FDA 510(k) clearance under submission number K982803, sponsored by Cardiac Telecom 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 1998-11-13.
- Submission: K982803
- Applicant / Sponsor: Cardiac Telecom Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 1998-11-13
Classification & Regulation
This clearance is catalogued under FDA product code QYX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.