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5f envoy guiding catheter modification
Cordis Neurovascular
Summary: The 5f Envoy Guiding Catheter is a medical device used to facilitate the delivery of interventional devices in neurovascular procedures. It is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K954251 ↗
Decision Date
October 23, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 5f Envoy Guiding Catheter by Cordis Neurovascular was cleared through the FDA 510(k) pathway on October 23, 1995. It is classified as a Class 2 device under product code DQY.
What It Is
The 5f Envoy Guiding Catheter is a flexible tube designed to provide a conduit for other devices to reach the neurovascular system. It is used to guide and support the placement of therapeutic devices such as stents or embolic agents. The catheter's design allows for navigation through the complex vascular pathways of the brain, ensuring precise delivery of treatment.
Clinical Applications
This device is commonly used in neurointerventional procedures, such as the treatment of cerebral aneurysms or arteriovenous malformations. It is utilized in hospital settings, particularly in the interventional radiology or neurosurgery departments. The catheter is suitable for adult patients requiring neurovascular interventions.
Indications for Use
The FDA indications suggest that this device is intended for use in patients requiring neurovascular access for the delivery of therapeutic devices. It is particularly useful in conditions where precise navigation through cerebral vessels is necessary.
Practical Considerations
The 5f Envoy 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 requires careful handling to navigate the delicate neurovascular structures.
Frequently Asked Questions
What is the 5f Envoy Guiding Catheter used for?
It is used to guide and support the delivery of therapeutic devices in neurovascular procedures.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for neurovascular access to deliver therapeutic devices in the treatment of conditions like cerebral aneurysms.
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.