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lead heart butterfly clamp
Arco Medical Products
Summary: The lead heart butterfly clamp is a Class 3 medical device used in cardiovascular procedures to secure and stabilize leads. It is primarily used by cardiothoracic surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K770416 ↗
Decision Date
March 10, 1977
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The lead heart butterfly clamp was cleared through the FDA 510k pathway on March 10, 1977. It is manufactured by Arco Medical Products and classified as a Class 3 device.
What It Is
The lead heart butterfly clamp is a surgical device designed to secure cardiac leads during cardiovascular procedures. It functions by clamping onto the lead, providing stability and preventing dislodgement during and after surgery. This device is essential in procedures where precise lead placement is critical, such as pacemaker or defibrillator implantations.
Clinical Applications
This device is commonly used in cardiothoracic surgery, particularly in procedures involving the implantation of pacemakers or defibrillators. It is utilized in hospital operating rooms and cardiac catheterization labs. The primary patient population includes those with arrhythmias or heart failure requiring device implantation.
Indications for Use
The lead heart butterfly clamp is indicated for use in securing cardiac leads during surgical procedures. It is specifically designed for patients undergoing pacemaker or defibrillator implantation, ensuring stable lead placement.
Practical Considerations
The clamp is typically available in various sizes to accommodate different lead diameters. It is compatible with standard cardiac leads and requires careful handling to avoid lead damage. Proper technique is essential to ensure secure placement and prevent complications.
Related Literature
The linked study focuses on lipid and glycogen metabolism in patients with impaired glucose tolerance and calcium sensing receptor mutations. Although the study's abstract is not available, it likely explores metabolic pathways affected by these conditions. The study's relevance to the lead heart butterfly clamp is unclear, as it does not directly address device-specific outcomes or applications.
Frequently Asked Questions
What is the lead heart butterfly clamp used for?
It is used to secure cardiac leads during procedures like pacemaker or defibrillator implantation.
What specialties typically use this device?
Cardiothoracic surgeons and interventional cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for securing cardiac leads during surgical procedures, particularly in pacemaker or defibrillator implantations.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.