Clearance Summary
MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM received FDA 510(k) clearance under submission number K014223, sponsored by Medtronic Percusurge, 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 2002-01-25.
- Submission: K014223
- Applicant / Sponsor: Medtronic Percusurge, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2002-01-25
Classification & Regulation
This clearance is catalogued under FDA product code NFA and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.