Clearance Summary
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR received FDA 510(k) clearance under submission number K861368, 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 1986-08-04.
- Submission: K861368
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1750
- Decision date: 1986-08-04
Classification & Regulation
This clearance is catalogued under FDA product code JOQ and 21 CFR 870.1750, within the Cardiovascular review panel as a Class II device.