Clearance Summary
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 received FDA 510(k) clearance under submission number K003084, sponsored by Concentric Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-05-16.
- Submission: K003084
- Applicant / Sponsor: Concentric Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2001-05-16
Classification & Regulation
This clearance is catalogued under FDA product code DQX and 21 CFR 870.1330, within the Cardiovascular review panel as a Class II device.