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Daig Percutaneous Catheter Intro Removable Hemo
Daig
Summary: The Daig Percutaneous Catheter Intro Removable Hemo is a Class 2 medical device used for vascular access in procedures requiring catheterization. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K894343 ↗
Decision Date ?
September 26, 1989
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on September 26, 1989, by Daig. It is classified as a Class 2 device under the product code DYB.
What It Is
The Daig Percutaneous Catheter Intro Removable Hemo is a medical device designed to facilitate the insertion of catheters into the vascular system. It typically consists of a sheath and dilator system that allows for smooth and safe access to blood vessels. This device is crucial in procedures where temporary vascular access is needed, such as in angiography or the placement of embolization coils.
FDA-Cleared Indications
- Percutaneous introduction of catheters into the vascular system.
- Temporary vascular access for procedures requiring catheterization.
- Use with compatible catheters and devices during vascular diagnostic or therapeutic interventions.
Clinical Applications
- Obtaining temporary arterial or venous access for angiography.
- Providing access for catheter-based embolization procedures.
- Facilitating placement and removal of compatible vascular catheters.
- Supporting minimally invasive vascular interventions in hospital or procedural settings.
Practical Considerations
- Select the introducer size and length based on the target vessel, patient anatomy and catheter or device requirements.
- Confirm compatibility between the introducer, dilator, guidewire and intended catheter or embolic device before use.
- Insertion and removal should be performed by trained clinicians using sterile technique and appropriate fluoroscopic or other image guidance.
- Review the device labeling for contraindications, warnings, pressure limits and handling instructions; vascular access risks include bleeding, hematoma, infection, thrombosis and vessel injury.
- MRI safety cannot be determined from the available FDA record alone. Check the current product labeling or manufacturer documentation before MRI exposure.
Procedures that use this device
Frequently Asked Questions
What is Daig Percutaneous Catheter Intro Removable Hemo used for?
It is used for gaining vascular access in procedures requiring catheterization, such as angiography or embolization.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for percutaneous access to the vascular system for diagnostic or therapeutic procedures.
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.