Vivio LVEDP System
by Avicena, LLC 510(k)
Active
510(k) K223905
Overview
The Vivio LVEDP System is a non-invasive adjunctive device classified as an Adjunctive Heart Failure Status Indicator (FDA Product Code: QUO). It measures left ventricular end-diastolic pressure (LVEDP), a key clinical indicator for diagnosing elevated filling pressure and heart failure. By providing real-time, non-invasive assessment, it aids clinicians in identifying at-risk patients without invasive procedures. The system operates as a standalone solution for primary care and expanded care settings, supporting early detection and intervention.
The Vivio LVEDP System is supplied as a portable, non-invasive device intended for single-use per patient assessment. It requires no sterilization and is designed for use in clinical environments where cardiovascular monitoring is conducted. The device is FDA-cleared under 510(k) K223905 as substantially equivalent to a predicate device, with classification under FDA Class II (870.2200). No MRI safety or reusable components are specified in the regulatory submission. Storage and handling instructions are not detailed in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223905 | Date6 Oct 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- QUO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Avicena, LLC
Questions
What is the Vivio LVEDP System used for?
The Vivio LVEDP System is a non-invasive adjunctive device designed to measure left ventricular end-diastolic pressure (LVEDP), a critical clinical indicator for diagnosing elevated filling pressure and heart failure. By offering real-time assessment, it helps clinicians identify at-risk patients early, enabling timely intervention in primary and expanded care settings.
How is the Vivio LVEDP System supplied and prepared for use?
The Vivio LVEDP System is supplied as a portable, standalone device intended for single-use per patient assessment. It does not require sterilization, making it convenient for clinical environments where cardiovascular monitoring is conducted. Each unit is designed for one-time use with a specific patient.
Is the Vivio LVEDP System reusable or single-use?
The Vivio LVEDP System is explicitly designed for single-use per patient assessment. This eliminates the need for sterilization or reprocessing, reducing the risk of contamination and ensuring consistent performance for each patient evaluation.
What regulatory approval does the Vivio LVEDP System hold?
The Vivio LVEDP System is FDA-cleared under the 510(k) process, specifically clearance number K223905. It is classified as substantially equivalent to a predicate device and falls under FDA Class II (870.2200) for adjunctive heart failure status indicators. This approval supports its use as a non-invasive tool for assessing heart failure risk.
Can the Vivio LVEDP System be used in settings without specialized equipment?
Yes, the Vivio LVEDP System is designed as a portable, standalone solution, making it suitable for primary care and expanded care settings where advanced cardiovascular monitoring infrastructure may not be available. Its non-invasive design allows for quick and convenient assessment without requiring invasive procedures.