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siterite needle guide modified
Dymax
Summary: The Siterite Needle Guide Modified by Dymax is a medical device used to assist in the accurate placement of needles during procedures. It is commonly used by clinicians in settings requiring precise needle guidance, such as vascular access or biopsy procedures.
FDA Clearance Information
Pathway
510K
Number
K931403 ↗
Decision Date
July 27, 1993
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Siterite Needle Guide Modified was cleared through the FDA 510k pathway on July 27, 1993. Manufactured by Dymax, it is classified as a Class 2 device under product code DQY.
What It Is
The Siterite Needle Guide Modified is a device designed to aid in the accurate placement of needles during medical procedures. It works by providing a stable and precise guide for the needle, reducing the risk of misplacement. This device is particularly useful in procedures where precision is critical, such as in the placement of venous stents or during biopsies.
Clinical Applications
Clinically, the Siterite Needle Guide Modified is used in procedures requiring precise needle placement, such as vascular access for venous stenting or obtaining tissue samples in biopsies. It is commonly used in interventional radiology, vascular surgery, and oncology settings. The device is beneficial for patient populations requiring frequent vascular access or those undergoing diagnostic or therapeutic procedures.
Indications for Use
The FDA-cleared indications for this device involve its use in procedures requiring accurate needle placement, particularly in the context of venous interventions. It is suitable for patients needing venous stents or undergoing procedures where precise needle guidance is necessary.
Practical Considerations
The Siterite Needle Guide Modified is typically compatible with a range of needle sizes and is designed to be used with standard ultrasound equipment. Clinicians should ensure proper alignment and stabilization of the guide to maximize accuracy during procedures.
Frequently Asked Questions
What is the Siterite Needle Guide Modified used for?
It is used to assist in the precise placement of needles during medical procedures, such as vascular access or biopsies.
What specialties typically use this device?
Specialties such as interventional radiology, vascular surgery, and oncology commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring accurate needle placement, particularly in venous interventions.
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.