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scimed r triduige r guide catheters
Scimed Life Systems
Summary: The Scimed R Triduige R Guide Catheters are used in interventional cardiology for guiding other devices into the coronary arteries. They are primarily used by cardiologists during procedures such as angioplasty or stent placement.
FDA Clearance Information
Pathway
510K
Number
K946204 ↗
Decision Date
March 13, 1995
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed R Triduige R Guide Catheters were cleared through the FDA 510(k) pathway on March 13, 1995. Manufactured by Scimed Life Systems, this device is classified as Class 2 under the product code DQY.
What It Is
The Scimed R Triduige R Guide Catheters are medical devices designed to facilitate the introduction and guidance of interventional tools into the coronary arteries. These catheters are essential in procedures like angioplasty, where precise navigation through the vascular system is critical. They are typically constructed from flexible materials that allow for maneuverability within the vascular anatomy.
Clinical Applications
These guide catheters are commonly used in interventional cardiology, particularly during percutaneous coronary interventions (PCIs) such as angioplasty and stent placement. They are used in catheterization labs by interventional cardiologists to treat patients with coronary artery disease. The device is crucial for accessing coronary arteries and delivering therapeutic devices to the site of a lesion.
Indications for Use
The FDA-cleared indications for the Scimed R Triduige R Guide Catheters involve their use in procedures requiring vascular access and guidance of interventional devices. They are intended for patients undergoing coronary interventions, particularly those with coronary artery disease requiring stent placement or angioplasty.
Practical Considerations
These guide catheters come in various sizes to accommodate different patient anatomies and procedural needs. They are compatible with standard interventional tools and require careful handling to ensure accurate placement. Clinicians should be familiar with the catheter's flexibility and torque response to optimize procedural outcomes.
Related Literature
The linked study investigated the use of advanced MRI techniques to assess myocardial injury in a porcine model. It demonstrated the potential for real-time molecular MRI to target early myocardial injury using MPIO-based contrast agents. Key findings included the effectiveness of T1 mapping in detecting ischemic lesions shortly after ischemia/reperfusion. Limitations include the study's animal model, which may not fully replicate human pathology.
Frequently Asked Questions
What is Scimed R Triduige R Guide Catheters used for?
They are used to guide interventional devices into coronary arteries during procedures like angioplasty and stent placement.
What specialties typically use this device?
Interventional cardiologists use these guide catheters in catheterization labs for coronary interventions.
What are the FDA-cleared indications?
The device is indicated for use in vascular access and guidance of interventional tools during coronary interventions.
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.