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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
510K
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.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures that require vascular access, such as angiography, embolization, and other catheter-based interventions. It is suitable for use in both hospital and outpatient settings, and is often employed in adult and pediatric patient populations requiring minimally invasive procedures.
Indications for Use
The FDA indications suggest this device is used for gaining percutaneous access to the vascular system, which is essential in procedures like angiography or the placement of embolization coils. It is intended for patients who require temporary vascular access for diagnostic or therapeutic interventions.
Practical Considerations
Clinicians should consider the appropriate size of the catheter intro based on the patient's anatomy and the specific procedure. Compatibility with other vascular devices and the technique for insertion should be reviewed to ensure optimal outcomes. Proper training in vascular access techniques is recommended for users.
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.