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softtouch guide catheter
Mallinckrodt Medical
Summary: The softtouch guide catheter is a medical device used in vascular procedures, primarily by interventional radiologists and cardiologists. It is designed to facilitate the placement of venous stents and other interventions.
FDA Clearance Information
Pathway
510K
Number
K934685 ↗
Decision Date
April 7, 1994
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The softtouch guide catheter was cleared through the FDA 510(k) pathway on April 7, 1994. Manufactured by Mallinckrodt Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The softtouch guide catheter is a flexible tube used to navigate through blood vessels, providing a pathway for other devices like stents or balloons. It is designed to offer support and stability during vascular procedures, ensuring precise delivery of therapeutic devices. Its construction allows for smooth navigation through the vascular system, minimizing trauma to vessel walls.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures involving venous access and stenting. It is particularly useful in settings where precise placement of venous stents is required, such as in patients with venous obstructions or thrombosis. The softtouch guide catheter is suitable for use in hospitals and specialized clinics, catering to adult and pediatric populations with vascular conditions.
Indications for Use
The FDA-cleared indications for the softtouch guide catheter include its use in facilitating the placement of venous stents. It is intended for patients with conditions that require vascular intervention, such as venous blockages or thrombosis.
Practical Considerations
The softtouch guide catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of stents and other interventional devices. Clinicians should be familiar with its handling characteristics to optimize procedural outcomes and minimize complications.
Frequently Asked Questions
What is the softtouch guide catheter used for?
The softtouch guide catheter is used to facilitate the placement of venous stents and other vascular interventions.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use the softtouch guide catheter in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the placement of venous stents in patients with vascular conditions.
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.