Clearance Summary
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) received FDA 510(k) clearance under submission number K172423, sponsored by Edwards Lifescience, 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 2018-02-20.
- Submission: K172423
- Applicant / Sponsor: Edwards Lifescience, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1230
- Decision date: 2018-02-20
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.