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boston scientific 6f runway guide catheter
Boston Scientific
Summary: The Boston Scientific 6F Runway Guide Catheter is a medical device used primarily in vascular procedures to facilitate the placement of other devices. It is typically used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K033441 ↗
Decision Date
November 21, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Boston Scientific 6F Runway Guide Catheter was cleared through the FDA 510(k) pathway on November 21, 2003. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The Boston Scientific 6F Runway Guide Catheter is a flexible tube designed to provide a conduit for the delivery of interventional devices into the vascular system. It is used to navigate through blood vessels and provide support for other devices, such as stents or balloons, during procedures. The catheter's design allows for precise control and stability, which is crucial during complex vascular interventions.
Clinical Applications
This guide catheter is commonly used in procedures involving the placement of venous stents, particularly in the treatment of venous obstructions or insufficiencies. It is frequently utilized in interventional cardiology and radiology settings, where precise device delivery is essential. The device is suitable for adult patients requiring vascular interventions, and its use is often seen in hospital catheterization labs.
Indications for Use
The FDA-cleared indications for this device include its use in facilitating the placement of interventional devices within the vascular system. It is specifically indicated for procedures involving venous stents, making it suitable for patients with venous blockages or structural issues.
Practical Considerations
The 6F size refers to the outer diameter of the catheter, which is compatible with a range of interventional devices. Clinicians should ensure compatibility with the specific devices being used. Proper technique in catheter handling and placement is crucial to avoid vascular trauma or complications.
Frequently Asked Questions
What is the Boston Scientific 6F Runway Guide Catheter used for?
It is used to facilitate the placement of interventional devices, such as stents, within the vascular system.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving the placement of venous stents, particularly in cases of venous obstructions.
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.