Clearance Summary
24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 received FDA 510(k) clearance under submission number K012143, sponsored by Medtronic Cardiac Surgical Products. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2001-10-24.
- Submission: K012143
- Applicant / Sponsor: Medtronic Cardiac Surgical Products
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1280
- Decision date: 2001-10-24
Classification & Regulation
This clearance is catalogued under FDA product code DRA and 21 CFR 870.1280, within the Cardiovascular review panel as a Class II device.