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scimed 10 fr large lumen triguide-flex guid cath
Scimed Life Systems
Summary: The Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath is a catheter used primarily in venous stenting procedures. It is utilized by interventional radiologists and cardiologists to facilitate the placement of stents in venous systems.
FDA Clearance Information
Pathway
510K
Number
K940545 ↗
Decision Date
May 6, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath was cleared through the FDA 510(k) pathway on May 6, 1994. Manufactured by Scimed Life Systems, it is classified as a Class 2 medical device.
What It Is
The Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath is a guiding catheter designed to assist in the placement of stents within the venous system. It features a large lumen to accommodate various guidewires and devices, enhancing the precision and ease of stent deployment. The catheter's flexible design allows for navigation through complex vascular anatomy, making it a valuable tool in interventional procedures.
Clinical Applications
This device is commonly used in interventional radiology and cardiology settings for procedures involving venous stenting. It is particularly useful in treating conditions such as venous obstructions or stenosis. The catheter is often employed in hospital settings, where it aids in the accurate placement of stents in patients with compromised venous flow, improving circulation and reducing symptoms.
Indications for Use
The FDA-cleared indications for this device include its use in procedures requiring venous stenting. It is suitable for patients with venous blockages or narrowing, where stent placement can restore proper blood flow.
Practical Considerations
The Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath typically comes in a 10 French size, which is compatible with a range of guidewires and stents. Clinicians should ensure compatibility with other procedural equipment and consider the patient's vascular anatomy when selecting this device.
Frequently Asked Questions
What is the Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath used for?
It is used for guiding the placement of stents in the venous system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in venous stenting procedures to treat venous obstructions or stenosis.
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.