Clearance Summary
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD received FDA 510(k) clearance under submission number K973360, sponsored by Medtronic Vascular. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-05-26.
- Submission: K973360
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 1998-05-26
Classification & Regulation
This clearance is catalogued under FDA product code LDF and 21 CFR 870.3680, within the Cardiovascular review panel as a Class II device.