📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for the percutaneous introduction of catheters and other intravascular devices.
- Use as an introducer system during procedures that require catheter or device placement within the vascular system.
Clinical Applications
- Obtaining percutaneous vascular access before catheter-based treatment.
- Introducing diagnostic or therapeutic catheters into blood vessels.
- Providing access for interventional procedures in catheterization laboratories and interventional suites.
Practical Considerations
- The kit is available in different sizes; the selected sheath and dilator must match the target vessel, access route and intended catheter or device.
- Use requires sterile technique, wire-guided or coaxial insertion technique, and imaging guidance appropriate to the procedure.
- Compatibility depends on the sheath inner diameter, dilator dimensions and the outside diameter of the catheter or device being introduced.
- The FDA record does not establish that every configuration is MRI safe; MRI labeling should be checked for the specific catalog number and components before scanning.
- Potential access-site complications include bleeding, hematoma, infection, vessel injury, thrombosis and, rarely, embolization. Contraindications and precautions depend on the planned procedure and patient condition.
Procedures that use this device
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.