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scimed angiographic kits
Scimed Life Systems
Summary: Scimed Angiographic Kits are used in angiographic procedures to visualize blood vessels. They are primarily used by interventional radiologists and cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K953265 ↗
Decision Date
January 16, 1996
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed Angiographic Kits were cleared through the FDA 510(k) pathway on January 16, 1996. Manufactured by Scimed Life Systems, this device is classified as Class 2 under product code DQY.
What It Is
Scimed Angiographic Kits are medical devices used to perform angiography, a procedure that involves imaging blood vessels. These kits typically include catheters, guidewires, and contrast media necessary for the procedure. The device works by allowing the injection of contrast dye into the vascular system, which is then visualized using imaging techniques such as X-ray. This helps in diagnosing and treating vascular conditions.
Clinical Applications
These kits are commonly used in procedures such as coronary angiography, peripheral angiography, and cerebral angiography. Interventional cardiologists and radiologists use them in hospital settings to diagnose and evaluate conditions like coronary artery disease, peripheral vascular disease, and aneurysms. They are essential in both diagnostic and therapeutic interventions, particularly in patients with suspected or known vascular abnormalities.
Indications for Use
The FDA indications for Scimed Angiographic Kits include their use in visualizing blood vessels to diagnose and treat vascular conditions. They are suitable for patients with suspected blockages or abnormalities in their blood vessels.
Practical Considerations
When using Scimed Angiographic Kits, clinicians should consider the appropriate size and type of catheter for the specific vascular territory being examined. Compatibility with imaging equipment and contrast media should also be ensured. Proper technique in catheter insertion and contrast injection is crucial for optimal imaging results.
Frequently Asked Questions
What is Scimed Angiographic Kits used for?
Scimed Angiographic Kits are used for imaging blood vessels to diagnose and treat vascular conditions.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use these kits in hospital settings.
What are the FDA-cleared indications?
The kits are cleared for use in visualizing blood vessels to diagnose and treat vascular conditions.
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.