Electrode, Temporary Myocardial (K760513)

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

Full name

Electrode, Temporary Myocardial

510(k) Number

K760513 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Gauze Conversion Class II Sterile

  Unclassified

  FDA 510(k) K832213 Active Cleared 26 Jul 1983

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  Class I

  FDA 510(k) K830511 Active Cleared 17 Mar 1983

• Neurosponges

  Class I

  FDA 510(k) K812391 Active Cleared 24 Nov 1981

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  Class II

  FDA 510(k) K761155 Active Cleared 16 Dec 1976

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  FDA 510(k) K800195 Active Cleared 11 Feb 1980

• Blanket, Burn

  Class I

  FDA 510(k) K760365 Active Cleared 11 Aug 1976

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• What is the primary clinical purpose of this temporary myocardial electrode, and where is it typically used?

  This temporary myocardial electrode is designed to provide electrical stimulation of the heart muscle to manage or restore normal heart rhythm in patients experiencing transient bradycardia or requiring temporary cardiac pacing. It is intended for short-term use in controlled clinical environments like hospitals or cardiac care units, where precise pacing support is needed during acute cardiac events.

• Is this device single-use or reusable, and what does that mean for its clinical workflow?

  This electrode is classified as a reusable medical device, meaning it is intended for repeated use within a clinical setting after proper cleaning and maintenance. This design allows for flexibility in acute care scenarios where multiple patients may require temporary pacing, reducing the need for frequent restocking of single-use alternatives.

• What regulatory pathway was followed for FDA clearance of this device, and which committee reviewed it?

  The device received FDA clearance through the 510(k) Traditional pathway, with a Substantially Equivalent (SESE) determination. The review was conducted by the Cardiovascular (CV) Advisory Committee, ensuring its compliance with existing permanent pacemaker electrode standards before approval.

• Are there any specific storage requirements or considerations mentioned for this electrode?

  The provided data does not specify any particular storage requirements, such as temperature ranges or environmental conditions. However, since it is reusable, proper cleaning, sterilization (if applicable), and maintenance protocols should be followed to ensure safe and effective use in clinical settings.