đź“‹ FDA Reference
nexgen expandable catheter
Nexgen Medical Systems
Summary: The Nexgen Expandable Catheter is a medical device used for embolization procedures, primarily involving the placement of coils. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K102925 ↗
Decision Date
November 10, 2011
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Nexgen Expandable Catheter was cleared through the FDA 510(k) pathway on November 10, 2011. It is manufactured by Nexgen Medical Systems and classified as a Class 2 device under product code DYB.
What It Is
The Nexgen Expandable Catheter is a specialized catheter designed to facilitate the delivery of embolization coils into blood vessels. It features an expandable mechanism that allows for precise placement and deployment of coils, which are used to occlude blood flow to targeted areas, such as aneurysms or tumors. This device is engineered to provide enhanced control and accuracy during embolization procedures.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery for procedures involving the embolization of blood vessels. It is particularly useful in treating conditions like cerebral aneurysms, arteriovenous malformations, and certain types of tumors. The device is typically used in hospital settings, where advanced imaging and interventional capabilities are available, and is suitable for adult and pediatric patients requiring vascular occlusion.
Indications for Use
The FDA-cleared indications for the Nexgen Expandable Catheter include its use in embolization procedures where coils are needed to block blood flow. This is relevant for patients with vascular abnormalities or tumors that require reduced blood supply.
Practical Considerations
The Nexgen Expandable Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard embolization coils and requires fluoroscopic guidance for accurate placement. Clinicians should be trained in catheter-based interventions to ensure optimal outcomes.
Frequently Asked Questions
What is the Nexgen Expandable Catheter used for?
It is used for embolization procedures to deliver coils that occlude blood vessels, often in cases of aneurysms or tumors.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device during embolization procedures.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures requiring coil placement to block blood flow in specific vascular conditions.
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.