đź“‹ FDA Reference
cathcap cat no cc100 series
Gish Biomedical
Summary: The Cathcap CC100 Series by Gish Biomedical is a medical device used in venous stenting procedures. It is primarily utilized by interventional radiologists and vascular surgeons to support venous blood flow.
FDA Clearance Information
Pathway
510K
Number
K911519 ↗
Decision Date
May 22, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Cathcap CC100 Series received FDA clearance through the 510(k) pathway on May 22, 1991. Manufactured by Gish Biomedical, it is classified as a Class 2 device under product code DQY.
What It Is
The Cathcap CC100 Series is a type of venous stent designed to maintain patency in veins, particularly in cases where venous flow is compromised. It functions by providing structural support to the vein walls, preventing collapse and ensuring adequate blood flow. This device is crucial in managing conditions such as deep vein thrombosis or chronic venous insufficiency.
Clinical Applications
Clinically, the Cathcap CC100 Series is used in procedures involving venous stenting, often in the context of treating venous obstructions or insufficiencies. It is commonly employed in hospital settings, particularly in interventional radiology suites or vascular surgery departments. The device is suitable for adult patients experiencing venous blockages or those requiring long-term venous support.
Indications for Use
The FDA indications suggest that the Cathcap CC100 Series is intended for use in patients with compromised venous flow. This includes individuals with conditions like deep vein thrombosis or those needing structural support for veins post-surgery.
Practical Considerations
The Cathcap CC100 Series is available in various sizes to accommodate different vein diameters. Clinicians should ensure compatibility with existing venous access systems and be familiar with stenting techniques to optimize outcomes.
Frequently Asked Questions
What is the Cathcap CC100 Series used for?
It is used for maintaining venous patency in patients with compromised venous flow, such as those with deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in patients with compromised venous flow, providing structural support to veins.
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.