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arrow percutaneous sheath introducer kit ak-07903
Arrow Intl.
Summary: The Arrow Percutaneous Sheath Introducer Kit is a medical device used for vascular access, primarily by interventional radiologists and cardiologists. It facilitates the insertion of catheters and other devices into the vascular system.
FDA Clearance Information
Pathway
510K
Number
K940079 ↗
Decision Date
November 30, 1994
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Arrow Percutaneous Sheath Introducer Kit was cleared through the FDA 510(k) pathway on November 30, 1994. It is manufactured by Arrow Intl. and classified as a Class 2 device under product code DYB.
What It Is
The Arrow Percutaneous Sheath Introducer Kit is designed to provide percutaneous access to the vascular system. It includes a sheath and dilator, allowing for the insertion of catheters and other medical devices. This kit is particularly useful in procedures requiring stable and reliable vascular access, such as angiography or the placement of central venous catheters.
Clinical Applications
This device is commonly used in interventional radiology, cardiology, and surgery for procedures requiring vascular access. It is suitable for use in hospital settings, particularly in catheterization labs and operating rooms. The device is often used in adult patients requiring diagnostic or therapeutic interventions involving the vascular system.
Indications for Use
The FDA indications suggest that this device is intended for patients needing vascular access for procedures like catheterization. It is particularly useful when traditional methods of access are challenging or have failed.
Practical Considerations
The device is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and guidewires. Clinicians should be trained in percutaneous techniques to ensure successful and safe use.
Related Literature
The linked study describes a modified method of vascular access system implantation using the Arrow Percutaneous Sheath Introducer Kit via the subclavian vein. The study highlights the kit's utility in cases where traditional cutdown methods are unsuccessful or when the percutaneous technique is challenging. However, the study is limited by its age and lack of detailed outcome data.
Frequently Asked Questions
What is the Arrow Percutaneous Sheath Introducer Kit used for?
It is used for gaining percutaneous access to the vascular system to facilitate the insertion of catheters and other medical devices.
What specialties typically use this device?
Interventional radiologists, cardiologists, and surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for patients needing vascular access for procedures such as catheterization, particularly when traditional access methods are difficult.
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.