Cardiac Electrode K760443

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Cardiac Electrode

510(k) Number

K760443 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Meadox Medicals, Div. Boston Scientific Corp. →

• What is the primary purpose of this cardiac electrode, and how is it used in clinical settings?

  This device is a Permanent Pacemaker Electrode, designed to deliver electrical impulses to the heart to manage arrhythmias by maintaining proper cardiac rhythm. It is intended for chronic implantation in the myocardium or cardiac chambers, ensuring long-term support for patients with abnormal heart rhythms. It is specifically classified under FDA regulation 870.3680 and is used exclusively in cardiovascular procedures.

• Is this device meant for single-use or can it be reused after implantation?

  The Cardiac Electrode (K760443) is sterile and supplied for single-use implantation only. The data does not mention any reusable status or alternative sterilization methods, so it should not be reused after initial use to maintain safety and sterility standards.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its use?

  This device received FDA 510(k) clearance (K760443) under the Traditional Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for managing arrhythmias via chronic cardiac implantation.

• Are there multiple sizes or models available for this cardiac electrode?

  The provided data lists multiple FEI numbers (e.g., 3002618605, 1028232), which typically correspond to different models or variants of the device. While the exact specifications (e.g., lead length, electrode type, or fixation mechanism) are not detailed, these identifiers suggest the product may be available in various configurations to accommodate different patient anatomies or clinical needs. For precise sizing, refer to the manufacturer’s catalog or technical documentation.

• How should this device be stored before use, and what precautions should be taken?

  Since the device is sterile for single-use, it should be stored in its original packaging until implantation to preserve sterility. The data does not specify storage conditions (e.g., temperature, humidity), but standard medical practice dictates keeping it in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use. Always follow the manufacturer’s instructions for optimal shelf life and handling.