đź“‹ FDA Reference
upstream needle holder upstream needle holder with shut-off connector
Upstream Peripheral Technologies
Summary: The upstream needle holder with shut-off connector is a specialized device used in embolization procedures. It is primarily utilized by interventional radiologists and vascular surgeons to facilitate the delivery of embolization coils.
FDA Clearance Information
Pathway
510K
Number
K112887 ↗
Decision Date
March 21, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The upstream needle holder was cleared through the FDA 510(k) pathway on March 21, 2012, by Upstream Peripheral Technologies. It is classified as a Class 2 device under product code DYB.
What It Is
The upstream needle holder with shut-off connector is a medical device designed to assist in the precise placement and control of embolization coils during vascular procedures. It features a shut-off connector that allows for secure attachment and detachment of the needle, ensuring stability and accuracy. This device is essential in procedures where precise embolization is critical to patient outcomes.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings, particularly during embolization procedures aimed at treating aneurysms or controlling bleeding. It is suitable for use in hospitals and specialized clinics, and is often employed in adult and pediatric patients requiring precise vascular interventions.
Indications for Use
The upstream needle holder is indicated for use in procedures involving the placement of embolization coils. It is intended for patients requiring vascular embolization, such as those with aneurysms or arteriovenous malformations, to prevent hemorrhage or reduce blood flow to targeted areas.
Practical Considerations
Clinicians should consider the compatibility of the needle holder with existing embolization coils and catheters. The device is typically available in various sizes to accommodate different procedural needs, and proper technique is essential to ensure optimal outcomes and patient safety.
Frequently Asked Questions
What is the upstream needle holder used for?
It is used for the precise placement and control of embolization coils during vascular procedures.
What specialties typically use this device?
Interventional radiology and vascular surgery specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to treat aneurysms or control bleeding.
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.