📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Securing cardiac leads during cardiovascular surgical procedures.
- Stabilizing leads during procedures in which accurate lead placement is required.
Clinical Applications
- Securing cardiac leads during pacemaker implantation procedures.
- Securing cardiac leads during implantable cardioverter-defibrillator procedures.
- Stabilizing a cardiac lead during surgical lead placement or revision.
Practical Considerations
- The clamp must be selected and used according to the manufacturer's instructions and the diameter of the cardiac lead.
- Use compatible with the specific lead design; improper clamping can damage lead insulation or conductors.
- Careful handling and positioning are required to prevent lead displacement or injury to adjacent cardiac tissue.
- The FDA record provided does not establish MRI safety. MRI use should be determined from the complete implanted system's labeling, including the lead, generator and any accessories.
- The supplied record does not specify contraindications, dimensions, sterilization method or service life; consult the current manufacturer labeling.
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.