700-FR Series Radiolucent Stimulation Electrodes
by Cardiotronics Systems, Inc.
510(k) K964991
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964991 | Date15 Jan 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MKJ
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.5310
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The 700-FR Series Radiolucent Stimulation Electrodes are designed as radiolucent electrodes used in automated external defibrillators (non-wearable) for delivering electrical stimulation to the heart. These electrodes facilitate defibrillation by transmitting energy through the chest wall to restore normal cardiac rhythm during emergencies such as ventricular fibrillation or pulseless ventricular tachycardia.
These electrodes are supplied as single-use, sterile devices intended for use in emergency cardiac resuscitation settings. They are compatible with MRI environments due to their radiolucent properties, ensuring visibility during imaging procedures. The series includes various sizes and configurations, as referenced by the model numbers, and are regulated under FDA 510(k) clearance (K964991) with a classification as Class III medical devices. Storage and handling follow standard sterile medical device protocols.
Other devices from Cardiotronics Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What types of emergencies are these electrodes intended to address in cardiac resuscitation?
The 700-FR Series Radiolucent Stimulation Electrodes are specifically designed for use in automated external defibrillators (non-wearable) to deliver electrical stimulation during emergencies such as ventricular fibrillation or pulseless ventricular tachycardia. They help restore a normal cardiac rhythm by transmitting energy through the chest wall.
Are these electrodes reusable or single-use, and how should they be handled to maintain sterility?
These electrodes are single-use and supplied in a sterile package, meaning they are intended for one-time use only in emergency cardiac resuscitation settings. To maintain sterility, follow standard sterile medical device protocols, including keeping the packaging intact until immediate use and avoiding contamination before application.
Can these electrodes be used in MRI environments, and why is this important?
Yes, the 700-FR Series electrodes are radiolucent, meaning they allow X-rays to pass through, making them visible during imaging procedures. This is particularly important in MRI environments where visibility of the electrodes ensures proper placement and monitoring during cardiac resuscitation.
What regulatory pathway was followed for FDA clearance of these electrodes, and what classification do they hold?
The electrodes were cleared through the FDA 510(k) pathway (with clearance number K964991) under a traditional review process, determined to be substantially equivalent to a predicate device. They are classified as Class III medical devices, indicating they pose higher risks and require stringent regulatory oversight.
What sizes or configurations are available in the 700-FR Series, and how are they differentiated?
The series includes various sizes and configurations, though exact dimensions or model-specific details are not provided in the data. Typically, such electrodes are differentiated by model numbers (e.g., 700-FR variants) to accommodate different patient sizes or application needs in emergency defibrillation.