📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use during catheterization procedures when a hemostatic seal around a catheter or interventional device is needed.
- Use to control blood leakage while allowing catheters, guidewires, or other instruments to pass through the valve.
- Use with compatible catheterization equipment during procedures requiring controlled fluid or blood flow.
Clinical Applications
- Angiography and other catheter-based vascular procedures
- Embolization procedures requiring repeated passage of catheters or guidewires
- Interventional radiology procedures requiring a hemostatic catheter connection
- Interventional cardiology catheterization procedures
Practical Considerations
- Select a valve and tubing configuration compatible with the catheter, guidewire, sheath, and other connected equipment.
- Inspect connections and operate the valve according to the manufacturer's instructions to maintain the seal and reduce blood loss.
- Prime and flush the tubing as directed to limit air entry; improper handling can increase the risk of air embolism or loss of hemostasis.
- The FDA record provided does not establish MRI safety; review the current product labeling before use in or near an MRI environment.
- Contraindications, catheter-size limits, pressure limits, sterilization status, and reuse instructions should be confirmed in the current manufacturer labeling.
Procedures that use this device
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.