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daig obturator catheter introducer
Daig
Summary: The Daig Obturator Catheter Introducer is a medical device used to facilitate the insertion of catheters into blood vessels. It is commonly used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K884494 ↗
Decision Date
February 22, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Daig Obturator Catheter Introducer was cleared through the FDA 510(k) pathway on February 22, 1989. It is manufactured by Daig and classified as a Class 2 device under product code DYB.
What It Is
The Daig Obturator Catheter Introducer is a medical device designed to assist in the insertion of catheters into the vascular system. It typically consists of a sheath and an obturator that guides the catheter into place, minimizing trauma to the vessel. This device is essential in procedures requiring vascular access, providing a stable pathway for catheter placement.
Clinical Applications
This device is frequently used in interventional radiology and cardiology for procedures such as embolization, angiography, and catheter-based interventions. It is particularly useful in settings requiring precise vascular access, such as hospitals and specialized clinics. The introducer is suitable for adult patients requiring vascular interventions.
Indications for Use
The FDA indications suggest this device is used for facilitating the insertion of catheters into blood vessels, particularly in procedures involving embolization coils. It is intended for patients needing vascular access for diagnostic or therapeutic purposes.
Practical Considerations
The Daig Obturator Catheter Introducer comes in various sizes to accommodate different patient anatomies and catheter types. It is compatible with standard catheterization techniques and requires careful handling to avoid vessel injury. Clinicians should be familiar with the device's specifications and insertion techniques.
Frequently Asked Questions
What is the Daig Obturator Catheter Introducer used for?
It is used to facilitate the insertion of catheters into blood vessels, commonly in interventional radiology and cardiology procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device for vascular access during various procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating catheter insertion into blood vessels, particularly in procedures involving embolization coils.
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.