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7 french large lumen triguide-plus
Scimed Life Systems
Summary: The 7 French Large Lumen Triguide-Plus is a medical device used primarily in vascular procedures, particularly for venous stenting. It is utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K943783 ↗
Decision Date
October 13, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The 7 French Large Lumen Triguide-Plus was cleared via the FDA 510(k) pathway on October 13, 1994. Manufactured by Scimed Life Systems, it is classified as a Class 2 device under product code DQY.
What It Is
The 7 French Large Lumen Triguide-Plus is a catheter device designed for use in vascular interventions. It features a large lumen to facilitate the passage of instruments and contrast media, aiding in the placement of venous stents. Its design allows for precise navigation and deployment within the venous system, making it a valuable tool in complex vascular procedures.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures involving venous stenting. It is particularly useful in treating conditions such as venous obstructions or insufficiencies. The device is suitable for use in hospital settings, where comprehensive imaging and interventional capabilities are available, and is typically used in adult patient populations.
Indications for Use
The FDA-cleared indications for the 7 French Large Lumen Triguide-Plus include its use in procedures requiring venous stenting. It is intended for patients with conditions like venous blockages or other vascular abnormalities that necessitate stent placement.
Practical Considerations
The 7 French size indicates its compatibility with a wide range of vascular access points. Clinicians should ensure compatibility with other procedural instruments and consider the patient's vascular anatomy when selecting this device. Proper technique in catheter navigation and stent deployment is crucial for successful outcomes.
Frequently Asked Questions
What is the 7 French Large Lumen Triguide-Plus used for?
It is used for vascular procedures, particularly for placing venous stents in patients with venous obstructions or insufficiencies.
What specialties typically use this device?
Interventional radiologists and vascular surgeons primarily use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for use in venous stenting procedures, particularly for patients with venous blockages or vascular abnormalities.
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.