📋 FDA Reference
Devices for Vascu Intervent Rotat Hemostat Valve
Devices For Vascular Intervention
Summary: The rotational hemostat valve by Devices For Vascular Intervention is used in vascular procedures to control blood flow during catheterization. It is typically used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K914422 ↗
Decision Date ?
December 18, 1991
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on December 18, 1991. It is manufactured by Devices For Vascular Intervention and classified as a Class 2 device.
What It Is
The rotational hemostat valve is a medical device designed to manage blood flow during vascular interventions. It functions by providing a secure seal around catheters, allowing for controlled access to blood vessels while minimizing blood loss. This device is particularly useful in procedures requiring multiple catheter exchanges or adjustments.
FDA-Cleared Indications
- Use during percutaneous catheter-based procedures to provide hemostatic control around a catheter.
- Use to control blood or fluid flow during vascular catheterization and catheter manipulation.
Clinical Applications
- Maintaining a controlled seal during percutaneous vascular catheterization.
- Supporting catheter exchanges or adjustments during endovascular procedures.
- Controlling blood flow and limiting blood loss around an indwelling catheter.
- Use in catheterization laboratory procedures involving vascular access.
Practical Considerations
- The valve must be compatible with the catheter or guidewire diameter and the connection used in the procedure.
- Tighten the valve enough to maintain a seal, but avoid excessive force that could damage the catheter or restrict its movement.
- Inspect for leakage, damage, or loss of seal before and during use; replace the valve if it does not function properly.
- The available FDA record does not establish MRI safety. Follow the current product labeling and institutional MRI policies before bringing it into an MRI environment.
- Use is generally limited by the clinical procedure, access site, catheter system, and patient-specific bleeding or vascular risks rather than by the valve itself.
Procedures that use this device
Frequently Asked Questions
What is the rotational hemostat valve used for?
It is used to control blood flow during vascular interventions, particularly in catheterization procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is cleared for use in controlling blood flow during vascular access procedures, such as venous stent placements.
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.