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tec rotating dual hemovalve
Intensive Technology
Summary: The Tec Rotating Dual Hemovalve is a medical device used in embolization procedures to control blood flow. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K912664 ↗
Decision Date
August 24, 1992
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Tec Rotating Dual Hemovalve was cleared through the FDA 510k pathway on August 24, 1992. It is manufactured by Intensive Technology and classified as a Class 2 device under product code DYB.
What It Is
The Tec Rotating Dual Hemovalve is a specialized medical device designed to regulate blood flow during embolization procedures. It features a dual valve mechanism that allows precise control over the flow of embolic agents. This device is particularly useful in procedures requiring temporary occlusion of blood vessels to prevent excessive bleeding or to deliver therapeutic agents.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving the embolization of aneurysms, arteriovenous malformations, or tumors. The device is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The FDA indications suggest that the Tec Rotating Dual Hemovalve is intended for use in embolization procedures. This means it is used to block or reduce blood flow to specific areas, which can be beneficial in treating conditions like aneurysms or tumors.
Practical Considerations
The Tec Rotating Dual Hemovalve is available in various sizes to accommodate different vessel diameters. It is compatible with standard catheter systems used in embolization procedures. Clinicians should be familiar with the rotational mechanism to ensure precise control during use.
Frequently Asked Questions
What is the Tec Rotating Dual Hemovalve used for?
It is used to control blood flow during embolization procedures, often in the treatment of aneurysms or tumors.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to manage blood flow in specific clinical scenarios.
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.