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percutaneous sheath intro kit or tray
Stanco Medical
Summary: The percutaneous sheath intro kit by Stanco Medical is used for vascular access in interventional procedures. It is typically utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K792172 ↗
Decision Date
November 13, 1979
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on November 13, 1979, by Stanco Medical. It is classified as a Class 2 device under product code DYB.
What It Is
The percutaneous sheath intro kit is a medical device used to facilitate the insertion of catheters into blood vessels. It typically includes a sheath, dilator, and guidewire, allowing for safe and efficient vascular access. This device is crucial in procedures requiring the introduction of other instruments or fluids into the vascular system.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures such as angiography, embolization, and catheter-based interventions. It is essential in settings like hospitals and specialized clinics, particularly for patients requiring minimally invasive vascular procedures. The kit is used in both elective and emergency scenarios.
Indications for Use
The device is indicated for use in patients requiring vascular access for diagnostic or therapeutic procedures. It is suitable for conditions where catheterization of blood vessels is necessary, such as in the treatment of vascular diseases or during diagnostic imaging.
Practical Considerations
The kit typically comes in various sizes to accommodate different vessel diameters and patient anatomies. Compatibility with other vascular instruments is crucial, and clinicians should be familiar with the insertion technique to minimize complications such as vessel trauma or bleeding.
Frequently Asked Questions
What is the percutaneous sheath intro kit used for?
It is used for gaining vascular access to facilitate the insertion of catheters during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for vascular access in procedures requiring catheterization of blood vessels.
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.