PFA · Non-Invasive Central Venous Manometer
Cardiovascular · 21 CFR 870.1140 · Class 2
Overview
| Product Code | PFA |
|---|---|
| Device Name | Non-Invasive Central Venous Manometer |
| Regulation | 21 CFR 870.1140 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K151776 | Central Venous Pressure System | Mespere Lifesciences, Inc. | Aug 12, 2015 | SESE |
| K131085 | CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 | Mespere Lifesciences, Inc. | Aug 22, 2013 | SESE |
Top Applicants
- Mespere Lifesciences, Inc. — 2 clearances
