Clearance Summary
TRU-TRAC COILED GUIDEWIRE received FDA 510(k) clearance under submission number K880287, sponsored by N-S Medical Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-09-12.
- Submission: K880287
- Applicant / Sponsor: N-S Medical Products
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 1988-09-12
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.