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hemostasis valve and tubing set
Opticon Medical
Summary: The hemostasis valve and tubing set by Opticon Medical is used to control bleeding during catheter-based procedures. It is primarily utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K930194 ↗
Decision Date
September 22, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The hemostasis valve and tubing set by Opticon Medical was cleared through the FDA 510(k) pathway on September 22, 1993. It is a Class 2 medical device.
What It Is
This device is a hemostasis valve and tubing set designed to prevent blood loss during catheterization procedures. It functions by providing a seal around the catheter, allowing instruments to pass through while minimizing blood leakage. The device is crucial in maintaining a sterile field and ensuring patient safety during procedures.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is essential during procedures such as angiography and embolization. It is particularly useful in settings where maintaining hemostasis is critical, such as in patients with coagulopathy or during prolonged interventions. The device is suitable for both adult and pediatric populations, depending on the procedure.
Indications for Use
The device is indicated for use in procedures requiring vascular access and where control of blood flow is necessary. It is particularly beneficial in patients undergoing embolization or other catheter-based interventions.
Practical Considerations
The device typically comes in various sizes to accommodate different catheter diameters. It is compatible with standard catheterization equipment. Clinicians should ensure proper technique to maintain the seal and prevent air embolism.
Frequently Asked Questions
What is the hemostasis valve and tubing set used for?
It is used to control bleeding and maintain hemostasis during catheter-based procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for procedures requiring vascular access and blood flow control, such as embolization.
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.