Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1140](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1140) → PFA — Non-Invasive Central Venous Manometer

# PFA · Non-Invasive Central Venous Manometer

_Cardiovascular · 21 CFR 870.1140 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PFA

## Overview

- **Product Code:** PFA
- **Device Name:** Non-Invasive Central Venous Manometer
- **Regulation:** [21 CFR 870.1140](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1140)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PFA/K151776.md) | Central Venous Pressure System | Mespere Lifesciences, Inc. | Aug 12, 2015 | SESE |
| [K131085](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PFA/K131085.md) | CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000 | Mespere Lifesciences, Inc. | Aug 22, 2013 | SESE |

## Top Applicants

- Mespere Lifesciences, Inc. — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PFA](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PFA)

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