Clearance Summary
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN received FDA 510(k) clearance under submission number K061159, sponsored by Hospira, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2006-06-26.
- Submission: K061159
- Applicant / Sponsor: Hospira, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1230
- Decision date: 2006-06-26
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.