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Swan-Ganz Flow-Directed Thermodil Cath

by American Edwards Laboratories 510(k)

Active United States

510(k) K822350

Overview

The Swan-Ganz Flow-Directed Thermodil Cath is a flow-directed catheter used to monitor hemodynamic pressures. It is a type of catheter that provides a comprehensive hemodynamic profile, utilizing continuous data to track a patient's hemodynamic status. The catheter is used to sample mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters.

The Swan-Ganz Flow-Directed Thermodil Cath is supplied by American Edwards Laboratories and has FDA 510K clearance, with a product code of DYG and a regulation number of 870.1240. The device is classified as a Class 2 device, with a medical specialty description of Cardiovascular. The catheter is used in cardiovascular applications, with specific details on its use, sterility, and storage not provided in the available data.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822350 Date24 Aug 1982ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
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  • Expiring
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  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DYG
Device Class
Class II
Regulation
21 CFR Part 870.1240
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Swan-Ganz Flow-Directed Thermodil Cath used for?

    The Swan-Ganz Flow-Directed Thermodil Cath is used to monitor hemodynamic pressures and provide a comprehensive hemodynamic profile, utilizing continuous data to track a patient's hemodynamic status, particularly in cardiovascular applications.

  • Is the Swan-Ganz Flow-Directed Thermodil Cath supplied sterile?

    The available data does not provide specific details on the sterility of the Swan-Ganz Flow-Directed Thermodil Cath, it is recommended to consult the manufacturer or the device's labeling for this information.

  • What is the regulatory classification of the Swan-Ganz Flow-Directed Thermodil Cath?

    The Swan-Ganz Flow-Directed Thermodil Cath is classified as a Class 2 device with a regulation number of 870.1240 and has FDA 510K clearance.