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Swan-Ganz Bipolar Pacing Catheter

by American Edwards Laboratories 510(k)

Active United States

510(k) K822723

Overview

The Swan-Ganz Bipolar Pacing Catheter is a flow-directed catheter designed for temporary right ventricular endocardial pacing. It features a distal balloon that facilitates insertion by flow-direction and a pair of electrodes at the tip for bipolar pacing and electrocardiographic monitoring.

This intravascular catheter is inserted through the central vein to connect to the right side of the heart and advance towards the pulmonary artery. It provides temporary electrical cardiac stimulation to facilitate return to and/or continuance of normal cardiac rhythm. The device is classified as a Class II catheter and has FDA 510(k) clearance with the product code DYG.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK822723 Date15 Oct 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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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 purpose of the Swan-Ganz Bipolar Pacing Catheter?

    The Swan-Ganz Bipolar Pacing Catheter is designed for temporary right ventricular endocardial pacing. It provides temporary electrical cardiac stimulation to help restore or maintain normal cardiac rhythm when needed.

  • How is the Swan-Ganz Bipolar Pacing Catheter inserted and used?

    This intravascular catheter is inserted through the central vein to connect to the right side of the heart and advance toward the pulmonary artery. The distal balloon facilitates insertion by flow-direction, while the electrodes at the tip allow for bipolar pacing and electrocardiographic monitoring.

  • What are the regulatory classifications and approvals for this device?

    The Swan-Ganz Bipolar Pacing Catheter is classified as a Class II catheter and has FDA 510(k) clearance with the product code DYG. It was cleared through the traditional pathway in 1982 and is substantially equivalent to other devices in this category.

  • Is the Swan-Ganz Bipolar Pacing Catheter single-use or reusable?

    The device data does not specify whether the Swan-Ganz Bipolar Pacing Catheter is single-use or reusable. This information would typically be found in the device's instructions for use or labeling materials.