Clearance Summary
MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69 received FDA 510(k) clearance under submission number K033989, sponsored by Medtronic Inc. Cardiac Rhythm Management. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2004-01-22.
- Submission: K033989
- Applicant / Sponsor: Medtronic Inc. Cardiac Rhythm Management
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2004-01-22
Classification & Regulation
This clearance is catalogued under FDA product code DQY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.