Clearance Summary
Medtronic Temporary External Pacemaker 53401 received FDA 510(k) clearance under submission number K162054, sponsored by Medtronic, 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 2016-10-18.
- Submission: K162054
- Applicant / Sponsor: Medtronic, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3600
- Decision date: 2016-10-18
Classification & Regulation
This clearance is catalogued under FDA product code DTE and 21 CFR 870.3600, within the Cardiovascular review panel as a Class II device.