Clearance Summary
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 received FDA 510(k) clearance under submission number K013392, sponsored by Medtronic Vascular. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2002-01-25.
- Submission: K013392
- Applicant / Sponsor: Medtronic Vascular
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2002-01-25
Classification & Regulation
This clearance is catalogued under FDA product code OCL and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.