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subclavian gish model no svac-xxxx
Gish Biomedical
Summary: The Subclavian Gish Model No SVAC-XXXX is a venous stent used primarily in vascular procedures to support subclavian veins. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K863791 ↗
Decision Date
June 25, 1987
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Subclavian Gish Model No SVAC-XXXX was cleared through the FDA 510(k) pathway on June 25, 1987. Manufactured by Gish Biomedical, it is a Class 2 medical device.
What It Is
The Subclavian Gish Model No SVAC-XXXX is a venous stent designed to provide structural support to the subclavian vein, preventing collapse and maintaining patency. It is made from biocompatible materials suitable for long-term implantation. The stent is typically delivered via catheter and expanded in situ to fit the vein's dimensions.
Clinical Applications
This device is commonly used in procedures involving the subclavian vein, particularly in patients with venous obstruction or compression. It is frequently employed in settings such as hospitals and specialized vascular centers. Interventional radiologists and vascular surgeons are the primary users, often treating patients with conditions like thoracic outlet syndrome or post-thrombotic syndrome.
Indications for Use
The FDA indications for this device include maintaining patency in the subclavian vein, particularly in cases of stenosis or occlusion. It is suitable for patients experiencing symptoms related to impaired venous return in the upper extremities.
Practical Considerations
The stent comes in various sizes to accommodate different patient anatomies. It is crucial to ensure compatibility with the delivery system and to follow precise deployment techniques to avoid complications. Pre-procedural imaging is recommended to select the appropriate size and placement strategy.
Frequently Asked Questions
What is Subclavian Gish Model No SVAC-XXXX used for?
It is used to maintain patency in the subclavian vein, preventing collapse and ensuring proper blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons are the primary users of this device.
What are the FDA-cleared indications?
The device is indicated for use in maintaining patency of the subclavian vein, especially in cases of stenosis or occlusion.
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.