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guideliner catheter models 5571 5572 5573
Vascular Solutions
Summary: The Guideliner Catheter is a medical device used to facilitate the delivery of interventional devices in coronary and peripheral vascular procedures. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K091750 ↗
Decision Date
November 4, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Guideliner Catheter, manufactured by Vascular Solutions, was cleared by the FDA via the 510k pathway on November 4, 2009. It is a Class 2 device under product code DQY.
What It Is
The Guideliner Catheter is an extension catheter designed to provide additional support and access during complex vascular procedures. It is inserted through the existing guide catheter to enhance the delivery of stents and other interventional tools. This device is particularly useful in cases where additional reach or stability is needed to navigate challenging vascular anatomy.
Clinical Applications
The Guideliner Catheter is commonly used in interventional cardiology and radiology to assist in the placement of stents and other devices in coronary and peripheral arteries. It is particularly beneficial in procedures involving tortuous or calcified vessels where standard guide catheters may not provide sufficient support. The device is used in hospital settings, predominantly in catheterization labs, and is suitable for adult patients requiring complex vascular interventions.
Indications for Use
The FDA indications for the Guideliner Catheter include its use in facilitating the delivery of interventional devices in the treatment of vascular diseases. It is intended for patients with coronary or peripheral artery disease requiring stent placement or other interventional procedures.
Practical Considerations
The Guideliner Catheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guide catheters and should be selected based on the specific anatomical and procedural requirements. Clinicians should be familiar with its insertion technique to maximize its benefits.
Frequently Asked Questions
What is the Guideliner Catheter used for?
The Guideliner Catheter is used to facilitate the delivery of interventional devices during coronary and peripheral vascular procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists typically use the Guideliner Catheter in catheterization labs.
What are the FDA-cleared indications?
The FDA-cleared indications include facilitating the delivery of interventional devices in the treatment of coronary and peripheral artery diseases.
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.