đź“‹ FDA Reference
m2 navigation catheter and guideliner navigation catheter
Vascular Solutions
Summary: The m2 navigation catheter is a medical device used to facilitate the placement of guidewires and other devices in the vascular system. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K112100 ↗
Decision Date
March 20, 2012
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The m2 navigation catheter, manufactured by Vascular Solutions, was cleared by the FDA via the 510k pathway on March 20, 2012. It is classified as a Class 2 device under product code DQY.
What It Is
The m2 navigation catheter is a specialized tool designed to aid in the navigation of guidewires and other devices through the vascular system. It features a flexible design that allows for easy maneuverability within blood vessels, making it particularly useful in complex vascular procedures. The catheter is typically used in conjunction with imaging techniques to ensure precise placement.
Clinical Applications
This device is commonly used in interventional cardiology and radiology procedures, such as angioplasty or stent placement. It is particularly beneficial in cases where vascular access is challenging, such as in tortuous or narrow vessels. The catheter is suitable for use in both hospital and outpatient settings, and is often employed in adult patients undergoing vascular interventions.
Indications for Use
The FDA-cleared indications for the m2 navigation catheter include its use in facilitating the placement of guidewires and other devices within the vascular system. It is intended for patients requiring vascular interventions, particularly those with complex vascular anatomy.
Practical Considerations
The m2 navigation catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and is designed for use with fluoroscopic imaging to enhance procedural accuracy. Clinicians should be familiar with catheter manipulation techniques to optimize outcomes.
Frequently Asked Questions
What is the m2 navigation catheter used for?
The m2 navigation catheter is used to facilitate the placement of guidewires and other devices in the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use the m2 navigation catheter in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the placement of guidewires and other devices in the vascular system, particularly in complex vascular anatomy.
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.