← Back to catalogue

Cardiac Performance Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K864583

by Vascular Technology Incorporated

Identifiers

510(k) Number
K864583 FDA 510(k)
FDA Product Code
DQK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1425 FDA 510(k)
Regulation Number
870.1425 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A cardiac performance monitor is a device used to assess cardiac function. It is designed to monitor and evaluate the performance of the heart, typically through physiological signals.

This device is supplied as a reusable electronic module and was cleared via the FDA 510(k) process under K864583. It is intended for use in clinical settings where cardiac performance assessment is required, and its authorization is based on substantial equivalence to a predicate device.

Frequently asked questions

What is the CARDIAC PERFORMANCE MONITOR used for?

The CARDIAC PERFORMANCE MONITOR is used to assess cardiac function by monitoring and evaluating heart performance through physiological signals, intended for clinical settings where cardiac performance assessment is required.

How is the CARDIAC PERFORMANCE MONITOR supplied and is it reusable?

The device is supplied as a reusable electronic module, meaning it is designed for multiple uses after appropriate cleaning and maintenance, not as a single-use disposable product.

What regulatory pathway was used for the CARDIAC PERFORMANCE MONITOR?

The CARDIAC PERFORMANCE MONITOR was cleared via the FDA 510(k) process under submission number K864583, based on substantial equivalence to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CARDIAC PERFORMANCE MONITOR (K864583) — FDA 510(k) | Innolitics, Cardiac Performance Monitor 510 (k) FDA Premarket Notification K864583 ..., Home | Vascular Technology, Incorporated (VTI), vTitan - Cardiac monitor

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Vascular Technology Incorporated

Sources (1)

  • FDA 510(k) K864583 24 fields · synced Sep 21, 2026