📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Vascular access for angiographic procedures.
- Introduction of contrast media into blood vessels for diagnostic imaging.
- Use in procedures requiring percutaneous access to the vascular system.
Clinical Applications
- Obtaining percutaneous vascular access before diagnostic angiography.
- Introducing contrast media during imaging of the arterial or venous system.
- Providing initial access for interventional procedures performed through the vascular system.
Practical Considerations
- Available sizes and configurations should be selected according to the access vessel, patient anatomy, and planned procedure.
- The needle may be supplied with or without a connection; compatibility with the access system and other angiographic equipment should be confirmed before use.
- Use requires clinicians trained in percutaneous vascular access and sterile technique.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, and accidental puncture of nearby structures.
- MRI safety cannot be determined from the FDA clearance record alone. Confirm the specific product's labeling and material composition before MRI use; do not assume the needle is MR safe or MR conditional.
Procedures that use this device
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.