Clearance Summary
CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 received FDA 510(k) clearance under submission number K131085, sponsored by Mespere Lifesciences, 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 2013-08-22.
- Submission: K131085
- Applicant / Sponsor: Mespere Lifesciences, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1140
- Decision date: 2013-08-22
Classification & Regulation
This clearance is catalogued under FDA product code PFA and 21 CFR 870.1140, within the Cardiovascular review panel as a Class II device.