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Pacing System Analyzer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K803313

by Medtronic Vascular

Identifiers

510(k) Number
K803313 FDA 510(k)
FDA Product Code
DTE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3600 FDA 510(k)
Regulation Number
870.3600 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pacing System Analyzer 5311 is an external pulse-generator device designed for evaluating cardiac pacing systems. It assesses key parameters such as impedance, output, and current to ensure proper pacing function and patient safety in cardiac rhythm management procedures.

This device is intended for use in clinical settings to verify lead placement and pacing efficacy. Supplied as a reusable diagnostic tool, it adheres to FDA 510(k) clearance under K803313 and is classified as a Class II medical device (DTE product code). No specific sterility or MRI safety information is provided in the regulatory data.

Frequently asked questions

What is the primary purpose of the Pacing System Analyzer 5311 in clinical settings?

The Pacing System Analyzer 5311 is designed to evaluate cardiac pacing systems externally, ensuring proper function by measuring key parameters like impedance, output, and current. It helps clinicians verify lead placement and confirm pacing efficacy during cardiac rhythm management procedures, which is critical for patient safety and treatment accuracy.

Is the Pacing System Analyzer 5311 intended for single-use or reusable applications?

The device is explicitly described as a reusable diagnostic tool, meaning it is built for repeated use in clinical settings rather than being discarded after a single procedure. This aligns with its role as an external pulse-generator analyzer rather than a disposable component.

What regulatory pathway was followed for FDA clearance of this device?

The Pacing System Analyzer 5311 underwent a traditional 510(k) clearance process through the FDA, classified under product code DTE (Diagnostic and Therapeutic Electrical). It was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device, with clearance granted on February 23, 1981.

Does the device require special handling or storage conditions?

The regulatory data does not specify any special sterility requirements or storage conditions for the Pacing System Analyzer 5311, as it is a reusable diagnostic tool. However, standard clinical practices for electrical medical devices—such as protection from moisture, dust, and physical damage—should be followed to maintain its functionality and ensure accurate readings.

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: Medtronic 5311 Pacing System Analyzer - Medtronic Vascular | FDA ..., Pacing systems - Medtronic, Medtronic A-V Pacing System Analyzer - Medtronic Vascular | FDA ..., K803313 FDA 510(k) - PACING SYSTEM ANALYZER | Medtronic Vascular, CareLink SmartSync™ device manager - Medtronic

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K803313 24 fields · synced Oct 6, 2026