Clearance Summary
RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE received FDA 510(k) clearance under submission number K901780, 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 1990-10-09.
- Submission: K901780
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 1990-10-09
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.