đź“‹ FDA Reference
angiography needle w wo connection
Dlp
Summary: The angiography needle by Dlp is a medical device used in procedures requiring vascular access, primarily by interventional radiologists and cardiologists. It facilitates the introduction of contrast media for imaging.
FDA Clearance Information
Pathway
510K
Number
K840923 ↗
Decision Date
April 17, 1984
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The angiography needle by Dlp was cleared through the FDA 510k pathway on April 17, 1984. It is a Class 2 device under product code DYB.
What It Is
This angiography needle is a specialized medical device designed to provide access to the vascular system. It is typically used to introduce contrast media into blood vessels, allowing for detailed imaging during angiographic procedures. The needle may come with or without a connection, depending on the specific procedural requirements.
Clinical Applications
Commonly used in interventional radiology and cardiology, this device is essential for procedures such as coronary angiography, peripheral angiography, and embolization. It is used in hospital settings, particularly in catheterization labs, and is suitable for adult and pediatric patients requiring vascular imaging.
Indications for Use
The FDA indications suggest this device is intended for use in procedures that require vascular access for the introduction of contrast agents. It is suitable for patients undergoing diagnostic imaging to assess vascular conditions.
Practical Considerations
The angiography needle is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard angiographic equipment. Clinicians should be trained in vascular access techniques to ensure safe and effective use.
Frequently Asked Questions
What is the angiography needle used for?
It is used for vascular access to introduce contrast media for imaging during angiographic procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists primarily use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring vascular access for the introduction of contrast agents.
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.