Clearance Summary
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD received FDA 510(k) clearance under submission number K031210, sponsored by Metronic, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-05-16.
- Submission: K031210
- Applicant / Sponsor: Metronic, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 2003-05-16
Classification & Regulation
This clearance is catalogued under FDA product code DTB and 21 CFR 870.3680, within the Cardiovascular review panel as a Class III device.