📋 FDA Reference
Percutaneous Introd W Sideport Three-Way Stopcock
Daig
Summary: The percutaneous introducer with sideport and three-way stopcock by Daig is a medical device used primarily in vascular procedures for accessing blood vessels. It is typically utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K910861 ↗
Decision Date ?
May 7, 1991
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510k pathway on May 7, 1991. Manufactured by Daig, it is classified as a Class 2 medical device under product code DYB.
What It Is
The percutaneous introducer with sideport is a medical device designed to facilitate vascular access. It includes a three-way stopcock, allowing for the administration of fluids or medications and the withdrawal of blood samples. This device is essential in procedures requiring precise vascular access, providing a stable and secure entry point into the vessel.
FDA-Cleared Indications
- Vascular access for introducing catheters or other instruments into the vascular system.
- Use during diagnostic or therapeutic procedures that require percutaneous access to a blood vessel.
Clinical Applications
- Establishing vascular access for angiography and diagnostic catheter procedures.
- Providing access for catheter-based vascular interventions, including embolization.
- Maintaining a controlled access route for administration or withdrawal of fluids during a vascular procedure.
- Use in hospital catheterization laboratories and interventional procedure suites when percutaneous vascular access is required.
Practical Considerations
- Select the introducer size and length to match the access vessel, planned catheter or instrument, and procedural requirements.
- Confirm compatibility between the introducer, dilator, guidewire, catheter, and any connected tubing or injection system.
- Use sterile technique and inspect the stopcock, sideport, sheath, and connections for damage or leakage before use.
- The sideport may be used for fluid administration, blood withdrawal, or pressure monitoring when appropriate to the procedure.
- MRI safety and conditional use should be confirmed from the current device labeling; do not assume the device is MRI safe based only on its classification.
Procedures that use this device
Frequently Asked Questions
What is the percutaneous introducer with sideport used for?
It is used for vascular access in procedures like angiography and catheter-based interventions.
What specialties typically use this device?
Interventional radiology and cardiology are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access, such as catheter introduction into the vascular system.
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.