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pathbuilder steerable introducer
Shanghai Microport Ep Medtech
Summary: The Pathbuilder Steerable Introducer is a medical device used to facilitate the introduction and positioning of catheters in the vascular system. It is typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K211530 ↗
Decision Date
February 8, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Pathbuilder Steerable Introducer was cleared through the FDA 510(k) pathway on February 8, 2022. Manufactured by Shanghai Microport Ep Medtech, it is classified as a Class 2 device under product code DYB.
What It Is
The Pathbuilder Steerable Introducer is a device designed to aid in the precise placement of catheters within the vascular system. It features a steerable tip that allows for enhanced maneuverability and control during procedures. This device is particularly useful in complex vascular interventions where precise catheter placement is critical.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly during procedures like embolization or catheter-based interventions. It is suitable for use in hospitals and specialized clinics, catering to adult patients who require vascular access for diagnostic or therapeutic purposes.
Indications for Use
The FDA indications for the Pathbuilder Steerable Introducer include its use in facilitating the introduction and positioning of diagnostic or therapeutic catheters in the vascular system. It is intended for patients requiring vascular interventions.
Practical Considerations
The Pathbuilder Steerable Introducer typically comes in various sizes to accommodate different patient anatomies. It is compatible with standard catheter systems and requires familiarity with steerable introducer techniques for optimal use.
Frequently Asked Questions
What is the Pathbuilder Steerable Introducer used for?
It is used to facilitate the introduction and positioning of catheters in the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction and positioning of diagnostic or therapeutic catheters in the vascular system.
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.