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modified label to percu intro w sideport 3-way
Daig
Summary: The Modified Label to Percu Intro w Sideport 3-Way is a medical device used primarily in interventional radiology and cardiology for procedures involving embolization coils. It is typically utilized by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K894430 ↗
Decision Date
August 9, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on August 9, 1989, by the manufacturer Daig. It is classified as a Class 2 device under product code DYB.
What It Is
The Modified Label to Percu Intro w Sideport 3-Way is a specialized introducer sheath with a sideport and three-way stopcock. It facilitates the introduction and manipulation of embolization coils or other interventional devices into the vascular system. The sideport allows for the administration of fluids or medications during procedures, enhancing procedural efficiency and safety.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as embolization, where coils are deployed to occlude blood vessels. It is particularly useful in treating aneurysms or controlling bleeding in various patient populations. The device is typically used in hospital settings, including catheterization labs and interventional suites.
Indications for Use
The device is indicated for use in procedures requiring the introduction of embolization coils into the vascular system. It is suitable for patients needing vascular occlusion, such as those with aneurysms or arteriovenous malformations.
Practical Considerations
The introducer sheath is available in various sizes to accommodate different vessel diameters. It is compatible with standard interventional tools and techniques, and clinicians should ensure proper sizing and secure placement to prevent complications.
Frequently Asked Questions
What is Modified Label to Percu Intro w Sideport 3-Way used for?
It is used for introducing and manipulating embolization coils in vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring the introduction of embolization coils 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.