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mini stick envi non-vascular introducer kit
Angiodynamics
Summary: The mini stick envi non-vascular introducer kit is a medical device used primarily for introducing instruments into non-vascular spaces. It is commonly used by interventional radiologists and other specialists in minimally invasive procedures.
FDA Clearance Information
Pathway
510K
Number
K170775 ↗
Decision Date
July 19, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The mini stick envi non-vascular introducer kit was cleared via the FDA 510k pathway on July 19, 2017. Manufactured by Angiodynamics, it is classified as a Class 2 device under product code DYB.
What It Is
This device is an introducer kit designed for non-vascular access, facilitating the insertion of various medical instruments into body cavities or spaces. It typically includes components such as a sheath and dilator, which help in creating a pathway for other devices. The kit is engineered to minimize trauma to tissues and is used in procedures requiring precise access to non-vascular areas.
Clinical Applications
The mini stick envi non-vascular introducer kit is often used in interventional radiology and other minimally invasive specialties. It is suitable for procedures like biopsy, drainage, or the placement of catheters in non-vascular spaces. The device is particularly useful in settings where precise access is critical, such as in oncology for tumor biopsies or in nephrology for kidney interventions.
Indications for Use
The device is indicated for use in procedures requiring access to non-vascular spaces, such as body cavities or organ systems. It is designed for patients needing minimally invasive interventions where traditional vascular access is not applicable.
Practical Considerations
The kit typically comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of medical instruments, and clinicians should be familiar with the specific technique for its insertion to ensure optimal outcomes.
Frequently Asked Questions
What is the mini stick envi non-vascular introducer kit used for?
It is used for introducing medical instruments into non-vascular spaces during minimally invasive procedures.
What specialties typically use this device?
Interventional radiology, oncology, nephrology, and other specialties involved in minimally invasive procedures.
What are the FDA-cleared indications?
The device is indicated for use in accessing non-vascular spaces for procedures like biopsies and catheter placements.
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.