📋 FDA Reference
Mini Stick Envi Non-Vascular Introducer Kit
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 ?
510(k)
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.
FDA-Cleared Indications
- For introducing instruments into non-vascular body spaces.
- For establishing access to non-vascular spaces during diagnostic or therapeutic procedures.
Clinical Applications
- Image-guided access to non-vascular body spaces.
- Placement of instruments or catheters during non-vascular interventional procedures.
- Access for procedures involving body cavities or organ systems when vascular access is not required.
Practical Considerations
- The kit may be available in different sheath and dilator sizes; the selected size should match the anatomy and instruments planned for the procedure.
- Use is generally performed with imaging guidance, such as ultrasound, fluoroscopy, CT, or another appropriate modality.
- Clinicians should confirm compatibility between the introducer, guidewire, dilator, catheter, and other instruments before use.
- The device is intended for single-use procedures unless the current labeling states otherwise; it should be inspected for package damage or defects before use.
- MRI safety depends on the specific kit components and whether any metallic or radiopaque components remain in the patient. The product labeling should be reviewed before MRI, and the device should not be assumed to be MRI safe.
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.