Search Results

The Katecho External Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-80 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) card1ac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum). The Katecho KDP-80 Defilb/Pace Electrodes are designed for, and to be used interchangeably with Physio Control Defibrillation Devices that use Quik Combo Electrodes.

KATECHO KDP-80 Defib/Pace Electrodes

I'm sorry, but without further context or additional documents, I cannot provide a detailed description of the acceptance criteria and the study that proves the device meets them. The provided text is a 510(k) clearance letter from the FDA for the "K-Defib/Pace Adult Electrode, Model KDP-80."

While the letter states that the device is "substantially equivalent" to legally marketed predicate devices, it does not contain the acceptance criteria, study details, or performance results that would allow me to populate the table and answer the specific questions you've asked. The letter confirms clearance based on a determination of substantial equivalence, which is a regulatory pathway, but it doesn't elaborate on the underlying performance data.

To provide the requested information, I would need access to the actual 510(k) submission or supporting performance studies conducted by Katecho, Inc.

Therefore, I cannot fulfill your request at this time.

Ask a specific question about this device