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scimed 8 fr triguideflex guiding catheters
Scimed Life Systems
Summary: The Scimed 8 Fr Triguideflex Guiding Catheters are used in interventional cardiology for guiding other devices into the vascular system. They are typically used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K913830 ↗
Decision Date
November 22, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed 8 Fr Triguideflex Guiding Catheters were cleared through the FDA 510(k) pathway on November 22, 1991. Manufactured by Scimed Life Systems, this device is classified as a Class 2 medical device.
What It Is
The Scimed 8 Fr Triguideflex Guiding Catheters are flexible tubes designed to navigate the vascular system, facilitating the introduction of interventional devices like stents or balloons. They are constructed to provide support and stability during procedures, ensuring accurate placement of therapeutic devices. The catheters are typically used in procedures requiring precise navigation through the vascular anatomy.
Clinical Applications
These guiding catheters are commonly used in interventional cardiology and radiology to assist in the placement of stents or other therapeutic devices within the venous system. They are essential in procedures such as angioplasty, where precise device placement is crucial. The catheters are used in hospital settings, primarily by cardiologists and interventional radiologists, for patients requiring vascular interventions.
Indications for Use
The FDA indications for the Scimed 8 Fr Triguideflex Guiding Catheters involve their use in guiding other medical devices into the vascular system. They are suitable for patients undergoing procedures that require the placement of stents or balloons within veins.
Practical Considerations
These catheters typically come in an 8 French size, which is compatible with a range of interventional devices. Clinicians should ensure compatibility with other devices used during procedures. Proper technique in catheter manipulation is essential to avoid vascular trauma.
Frequently Asked Questions
What is Scimed 8 Fr Triguideflex Guiding Catheters used for?
They are used to guide other medical devices into the vascular system during interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for guiding other devices into the vascular system, particularly during procedures involving venous stents.
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.