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arrow fischell kink resist percut sheath intro set
Arrow Intl.
Summary: The Arrow Fischell Kink Resist Percut Sheath Intro Set is a medical device used for vascular access during procedures requiring embolization coils. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K924607 ↗
Decision Date
April 22, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Arrow Fischell Kink Resist Percut Sheath Intro Set was cleared by the FDA via the 510(k) pathway on April 22, 1993. Manufactured by Arrow Intl., it is classified as a Class 2 device under product code DYB.
What It Is
The Arrow Fischell Kink Resist Percut Sheath Intro Set is designed to facilitate vascular access by providing a kink-resistant pathway for catheters and other devices. It is particularly useful in procedures requiring the placement of embolization coils. The sheath's design minimizes the risk of kinking, ensuring smooth insertion and manipulation of devices within the vasculature.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures involving embolization coils, such as treating aneurysms or arteriovenous malformations. It is suitable for use in both hospital and outpatient settings, and is often employed in adult and pediatric patient populations requiring precise vascular access.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring the introduction of embolization coils. It is intended for patients who need vascular access for the treatment of vascular abnormalities.
Practical Considerations
The Arrow Fischell Kink Resist Percut Sheath Intro Set is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires, and clinicians should be familiar with standard insertion techniques to optimize outcomes.
Frequently Asked Questions
What is the Arrow Fischell Kink Resist Percut Sheath Intro Set used for?
It is used for providing vascular access during procedures that require the introduction of embolization coils.
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 use in procedures requiring the introduction of embolization coils for treating vascular abnormalities.
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.