Clearance Summary
ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488 received FDA 510(k) clearance under submission number K063210, sponsored by Medtronic Inc. Cardiac Rhythm Management. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-03-15.
- Submission: K063210
- Applicant / Sponsor: Medtronic Inc. Cardiac Rhythm Management
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1330
- Decision date: 2007-03-15
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.