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sos bloodless needle
E-Z-Em
Summary: The SOS Bloodless Needle is a medical device used for procedures requiring embolization coils. It is primarily utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K914330 ↗
Decision Date
December 20, 1991
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The SOS Bloodless Needle was cleared through the FDA 510(k) pathway on December 20, 1991. Manufactured by E-Z-Em, it is classified as a Class 2 device under product code DYB.
What It Is
The SOS Bloodless Needle is a specialized medical device designed to facilitate the placement of embolization coils in blood vessels. It minimizes blood loss during procedures by providing a controlled and precise method of coil delivery. This device is particularly useful in interventional radiology for managing vascular abnormalities.
Clinical Applications
Commonly used in interventional radiology, the SOS Bloodless Needle is employed in procedures such as embolization to treat aneurysms or arteriovenous malformations. It is used in hospital settings, particularly in catheterization labs, and is suitable for adult and pediatric patients requiring vascular intervention.
Indications for Use
The FDA indications for the SOS Bloodless Needle include its use in embolization procedures, which involve blocking blood flow to certain areas, such as tumors or abnormal blood vessels, to prevent bleeding or reduce blood supply.
Practical Considerations
The SOS Bloodless Needle is available in various sizes to accommodate different vessel diameters. It is compatible with standard embolization coils and requires careful handling to ensure precise placement. Clinicians should be trained in vascular access techniques for optimal use.
Frequently Asked Questions
What is the SOS Bloodless Needle used for?
It is used for delivering embolization coils to block blood flow in specific vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures to manage vascular abnormalities.
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.