Clearance Summary
HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 received FDA 510(k) clearance under submission number K982876, sponsored by Guidant Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-11-10.
- Submission: K982876
- Applicant / Sponsor: Guidant Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 1998-11-10
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.