đź“‹ FDA Reference
fasguide
Target Therapeutics
Summary: The fasguide is a medical device used as a venous stent, primarily in interventional radiology and cardiology. It is designed to support veins and improve blood flow in patients with venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K951159 ↗
Decision Date
September 25, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The fasguide received FDA clearance through the 510k pathway on September 25, 1995. Manufactured by Target Therapeutics, it is classified as a Class 2 device under product code DQY.
What It Is
The fasguide is a venous stent designed to be placed within veins to maintain patency and improve blood flow. It is typically made from biocompatible materials and may include a hydrophilic coating to reduce thrombogenicity. The device is used in minimally invasive procedures and is guided into place using imaging techniques.
Clinical Applications
The fasguide is commonly used in procedures to treat venous obstructions, such as those caused by thrombosis or compression. It is often employed in interventional radiology and cardiology settings, particularly for patients with conditions like deep vein thrombosis (DVT) or chronic venous insufficiency. The device is suitable for use in both hospital and outpatient settings.
Indications for Use
The fasguide is indicated for patients with venous obstructions that require stenting to maintain vessel patency. It is used in conditions where improved venous blood flow is necessary, such as in cases of DVT or post-thrombotic syndrome.
Practical Considerations
The fasguide is available in various sizes to accommodate different vein diameters. It is compatible with standard catheter delivery systems and requires fluoroscopic guidance for accurate placement. Clinicians should be aware of potential thrombogenicity and consider anticoagulation protocols as needed.
Related Literature
The linked study investigated the thrombogenicity of hydrophilic versus nonhydrophilic microcatheters and guiding catheters in a swine model. It found that catheter material and coating significantly affected thrombogenicity, with hydrophilic coatings generally reducing thrombus formation. However, the study's limitations include its animal model and the specific catheter types tested, which may not directly translate to all clinical scenarios.
Frequently Asked Questions
What is fasguide used for?
The fasguide is used to maintain venous patency and improve blood flow in patients with venous obstructions.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use the fasguide in procedures involving venous stenting.
What are the FDA-cleared indications?
The fasguide is indicated for use in patients with venous obstructions requiring stenting to maintain vessel patency and improve blood flow.
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.