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neich nm advance catheter sheath introducer
Neich Medical(Shenzhen)
Summary: The Neich NM Advance Catheter Sheath Introducer is a medical device used to facilitate the introduction of catheters into the vascular system. It is typically used by interventional radiologists and cardiologists during procedures such as embolization.
FDA Clearance Information
Pathway
510K
Number
K020964 ↗
Decision Date
October 11, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Neich NM Advance Catheter Sheath Introducer was cleared through the FDA 510(k) pathway on October 11, 2002. It is manufactured by Neich Medical (Shenzhen) and is classified as a Class 2 device under product code DYB.
What It Is
The Neich NM Advance Catheter Sheath Introducer is a medical device designed to aid in the insertion of catheters into the vascular system. It consists of a sheath and dilator, which help in accessing blood vessels with minimal trauma. This device is essential in procedures requiring vascular access, providing a stable pathway for catheters and other devices.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings, particularly during embolization procedures where precise catheter placement is crucial. It is used in hospitals and specialized clinics, often in patients requiring treatment for vascular conditions. The introducer is vital for procedures involving embolization coils, ensuring safe and effective catheter navigation.
Indications for Use
The FDA-cleared indications for this device include its use in facilitating the introduction of catheters for embolization procedures. It is intended for patients requiring vascular access for therapeutic interventions.
Practical Considerations
The Neich NM Advance Catheter Sheath Introducer is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and embolization coils, and clinicians should be familiar with the technique for sheath insertion to minimize vascular trauma.
Frequently Asked Questions
What is the Neich NM Advance Catheter Sheath Introducer used for?
It is used to facilitate the introduction of catheters into the vascular system, particularly during embolization procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during vascular access procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating catheter introduction during embolization procedures in patients requiring vascular access.
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.