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fasguide catheter
Target Therapeutics
Summary: The fasguide catheter is a medical device used for guiding venous stents in interventional procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K935597 ↗
Decision Date
October 18, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The fasguide catheter was cleared through the FDA 510k pathway on October 18, 1994. It is manufactured by Target Therapeutics and is classified as a Class 2 medical device.
What It Is
The fasguide catheter is a specialized catheter designed for use in guiding venous stents during interventional procedures. It is constructed to navigate through the vascular system with precision, aiding in the placement of stents. The catheter's design minimizes thrombogenicity and enhances maneuverability, making it a valuable tool in complex vascular interventions.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures involving the placement of venous stents. It is particularly useful in treating conditions such as venous obstructions or stenosis. The fasguide catheter is utilized in both hospital and outpatient settings, catering to a diverse patient population requiring vascular interventions.
Indications for Use
The fasguide catheter is indicated for use in guiding stents within the venous system. It is suitable for patients with conditions that necessitate the placement of stents to maintain or improve venous blood flow.
Practical Considerations
The fasguide catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional equipment and requires careful handling to ensure optimal performance during procedures.
Related Literature
The linked study assessed the thrombogenicity of hydrophilic and nonhydrophilic microcatheters and guiding catheters in a swine model. It evaluated the impact of catheter material, coating, and implantation duration on thrombogenicity. Key findings indicated that hydrophilic coatings may reduce thrombogenicity, although the study's limitations include its animal model and the need for further human studies to validate these findings.
Frequently Asked Questions
What is the fasguide catheter used for?
The fasguide catheter is used for guiding venous stents during interventional procedures to treat venous obstructions or stenosis.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use the fasguide catheter in vascular interventions.
What are the FDA-cleared indications?
The fasguide catheter is indicated for use in guiding stents within the venous system to improve blood flow in patients with venous obstructions.
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.