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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 ?
510(k)
Number ?
K961280 ↗
Decision Date ?
May 15, 1996
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Intended for percutaneous intravascular use as a guide catheter during vascular procedures.
- Used to provide a pathway for the delivery and placement of compatible intravascular devices, including stents.
- The device is a Class II percutaneous catheter under FDA product code DQY, 21 CFR 870.1250.
Clinical Applications
- Providing vascular access and support during venous stent placement.
- Guiding compatible stents and other interventional devices through the vascular system.
- Supporting catheter-based treatment of venous obstruction when an intravascular device must be delivered to the target vessel.
- Use in hospital catheterization laboratories and interventional procedure suites.
Practical Considerations
- Available in 6F, 7F, 8F, 9F, and 10F sizes; selection depends on the vessel, access sheath, guidewire, and device being delivered.
- Confirm compatibility with the intended stent or other intravascular device before use.
- Use fluoroscopic or other appropriate imaging guidance and maintain sterile technique during advancement and device placement.
- The record provided does not establish MRI safety labeling; check the current manufacturer instructions for use before MRI exposure.
- Contraindications, warnings, and permitted guidewire or device combinations should be confirmed in the current labeling. General risks include bleeding, vessel injury, thrombosis, infection, embolization, and contrast-related complications.
Procedures that use this device
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.