📋 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 ?
510(k)
Number ?
K951159 ↗
Decision Date ?
September 25, 1995
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- The FDA record identifies the fasguide as a percutaneous catheter under product code DQY.
- The supplied FDA summary does not state a specific indication for venous stenting or treatment of venous obstruction.
Clinical Applications
- Percutaneous catheter-based vascular procedures, when used according to the original 510(k) labeling.
- Image-guided access or delivery within the vascular system, if included in the device's original instructions for use.
Practical Considerations
- The available record does not establish that fasguide is a venous stent; clinicians should review the original FDA clearance and manufacturer labeling before use.
- Use requires appropriate catheter compatibility, vessel sizing, and fluoroscopic or other intravascular imaging guidance.
- MRI safety cannot be determined from the supplied FDA record. Confirm MR Safe, MR Conditional, or MR Unsafe status in the current labeling.
- Contraindications, anticoagulation requirements, handling instructions, and storage conditions should be taken from the original instructions for use.
- The 1995 clearance does not by itself confirm current availability, labeling, or compatibility with modern delivery systems.
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.