Clearance Summary
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER received FDA 510(k) clearance under submission number K140129, sponsored by Icu Medical, 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 2014-07-02.
- Submission: K140129
- Applicant / Sponsor: Icu Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1230
- Decision date: 2014-07-02
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.