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softouch guiding catheter
Mallinckrodt Medical
Summary: The softouch guiding catheter is a medical device used in vascular procedures, particularly for guiding stents and other instruments through veins. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway
510K
Number
K905547 ↗
Decision Date
February 5, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The softouch guiding catheter was cleared through the FDA 510(k) pathway on February 5, 1991. Manufactured by Mallinckrodt Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The softouch guiding catheter is a flexible tube designed to navigate through the vascular system. It provides a conduit for other devices, such as stents or balloons, to be delivered to specific sites within the venous system. Its design allows for precise control and positioning, which is crucial during complex vascular interventions.
Clinical Applications
This device is commonly used in procedures involving venous stenting, where it helps guide the placement of stents in veins. It is frequently utilized in interventional radiology and cardiology settings, particularly in hospitals and specialized clinics. Patients with conditions such as venous obstructions or those requiring venous access for other interventions may benefit from its use.
Indications for Use
The softouch guiding catheter is indicated for use in patients requiring venous access for the placement of stents or other therapeutic devices. It is suitable for patients with venous blockages or those undergoing procedures that necessitate precise vascular navigation.
Practical Considerations
The softouch guiding catheter comes in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard interventional tools and requires careful handling to ensure accurate placement and minimize vascular trauma.
Frequently Asked Questions
What is softouch guiding catheter used for?
It is used to guide stents and other devices through the venous system during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in their procedures.
What are the FDA-cleared indications?
It is indicated for use in patients needing venous access for stent placement or other therapeutic interventions.
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.