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scimed 6-10 f triguide guide catheters 6f 7f 8f 9f 10f
Scimed Life Systems
Summary: The Scimed 6-10 F Triguide Guide Catheters are used in vascular procedures to guide stents and other devices into place. They are primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway 510K
Number K961280 ↗
Decision Date May 15, 1996
Product Code DQY
Device Class Class 2
Evidence 0 studies
The Scimed 6-10 F Triguide Guide Catheters were cleared through the FDA 510(k) pathway on May 15, 1996. Manufactured by Scimed Life Systems, they are classified as Class 2 devices.
What It Is
The Scimed 6-10 F Triguide Guide Catheters are flexible tubes designed to navigate through the vascular system. They are used to guide and support other devices, such as stents, during interventional procedures. The catheters come in various sizes, from 6F to 10F, to accommodate different anatomical and procedural needs.
Clinical Applications
These guide catheters are commonly used in interventional cardiology and radiology for procedures involving the placement of venous stents. They are essential in accessing difficult-to-reach areas within the vascular system, ensuring precise delivery of therapeutic devices. The catheters are typically used in hospital settings, particularly in catheterization labs.
Indications for Use
The FDA-cleared indications suggest that these catheters are intended for use in procedures that require the placement of venous stents. They are suitable for patients with vascular conditions that necessitate stenting to maintain vessel patency.
Practical Considerations
When selecting a catheter size, consider the vessel diameter and the specific procedural requirements. The catheters are compatible with a range of stents and other interventional devices. Proper technique is crucial to ensure successful navigation and placement within the vascular system.
Frequently Asked Questions
What is Scimed 6-10 F Triguide Guide Catheters used for?
They are used to guide and support the placement of venous stents and other interventional devices during vascular procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use these guide catheters.
What are the FDA-cleared indications?
They are indicated for use in procedures requiring the placement of venous stents to maintain vessel patency.
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.