Clearance Summary
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 received FDA 510(k) clearance under submission number K944956, sponsored by The Heart Valve Div. Medtronic Cardiovascular Surg. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-07-14.
- Submission: K944956
- Applicant / Sponsor: The Heart Valve Div. Medtronic Cardiovascular Surg
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 1995-07-14
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.