Clearance Summary
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR received FDA 510(k) clearance under submission number K011098, sponsored by Medtronic Vascular. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-05-04.
- Submission: K011098
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2001-05-04
Classification & Regulation
This clearance is catalogued under FDA product code MXC and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.