đź“‹ FDA Reference
medamicus coaxial introducer kit 10330-xxx boston scientific coaxial dilator set
Medamicus
Summary: The Medamicus Coaxial Introducer Kit is a medical device used for vascular access, primarily in interventional radiology and cardiology. It is designed for clinicians to facilitate the introduction of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K990705 ↗
Decision Date
June 28, 1999
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medamicus Coaxial Introducer Kit was cleared through the FDA 510k pathway on June 28, 1999. Manufactured by Medamicus, it is classified as a Class 2 device under product code DYB.
What It Is
The Medamicus Coaxial Introducer Kit is a set of medical tools used to gain access to the vascular system. It typically includes a dilator and sheath that allow for the smooth introduction of catheters and other interventional devices. The coaxial design aids in minimizing trauma to the vessel during insertion, which is crucial for patient safety and procedural success.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, such as embolization or catheter-based interventions. It is suitable for use in hospital settings, particularly in catheterization labs or interventional suites. The device is used by specialists who require precise vascular access, such as interventional radiologists and cardiologists, to treat conditions like vascular blockages or to deliver therapeutic agents.
Indications for Use
The FDA indications for this device include its use in procedures requiring vascular access for the introduction of catheters and other devices. It is intended for patients who need interventional procedures for conditions like vascular embolization.
Practical Considerations
The Medamicus Coaxial Introducer Kit comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and interventional tools. Clinicians should be familiar with the technique of coaxial insertion to optimize outcomes and reduce complications.
Frequently Asked Questions
What is the Medamicus Coaxial Introducer Kit used for?
It is used for vascular access to facilitate the introduction of catheters and other interventional devices into the vascular system.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in hospital settings for procedures requiring vascular access.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access for the introduction of catheters and other devices, particularly in interventional radiology and cardiology.
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.