Clearance Summary
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) received FDA 510(k) clearance under submission number K242705, sponsored by Medtronic, 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 2025-01-17.
- Submission: K242705
- Applicant / Sponsor: Medtronic, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 2025-01-17
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.