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5f envoy tm guiding catheter
Cordis Neurovascular
Summary: The 5f Envoy TM Guiding Catheter is a medical device used in neurovascular procedures to guide other instruments into the vasculature. It is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K945705 ↗
Decision Date
February 3, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 5f Envoy TM Guiding Catheter was cleared through the FDA 510(k) pathway on February 3, 1995. Manufactured by Cordis Neurovascular, it is classified as a Class II device under product code DQY.
What It Is
The 5f Envoy TM Guiding Catheter is designed to facilitate the introduction of interventional devices into the neurovascular system. It provides a stable and flexible conduit for the delivery of diagnostic and therapeutic tools. Its construction allows for precise navigation through the complex vasculature of the brain.
Clinical Applications
This catheter is commonly used in procedures such as cerebral angiography and endovascular interventions for aneurysms or arteriovenous malformations. It is utilized in hospital settings, particularly in interventional radiology and neurosurgery departments, where precise vascular access is critical.
Indications for Use
The device is indicated for use in patients requiring neurovascular access for diagnostic or therapeutic procedures. It is suitable for conditions involving the cerebral vasculature, such as aneurysms or vascular malformations.
Practical Considerations
The 5f Envoy TM Guiding Catheter typically comes in various lengths and diameters to accommodate different patient anatomies and procedural needs. It is compatible with a range of interventional devices, and clinicians should be familiar with its handling characteristics to optimize procedural outcomes.
Frequently Asked Questions
What is the 5f Envoy TM Guiding Catheter used for?
It is used to guide other medical instruments into the neurovascular system for diagnostic and therapeutic procedures.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use this device in neurovascular procedures.
What are the FDA-cleared indications?
The device is cleared for use in accessing the neurovascular system for diagnostic and therapeutic purposes, particularly in conditions affecting the cerebral vasculature.
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.