Clearance Summary
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR received FDA 510(k) clearance under submission number K053609, sponsored by Edwards Lifesciences, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-02-28.
- Submission: K053609
- Applicant / Sponsor: Edwards Lifesciences, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1230
- Decision date: 2006-02-28
Classification & Regulation
This clearance is catalogued under FDA product code DQE and 21 CFR 870.1230, within the Cardiovascular review panel as a Class II device.