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softtouch r guiding catheter
Mallinckrodt Medical
Summary: The softtouch r guiding catheter is a medical device used primarily in interventional radiology and cardiology for guiding stents and other devices into veins. It is typically used by specialists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K912199 ↗
Decision Date
July 30, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The softtouch r guiding catheter was cleared through the FDA 510(k) pathway on July 30, 1991. Manufactured by Mallinckrodt Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The softtouch r guiding catheter is a flexible tube designed to facilitate the placement of stents and other devices within the venous system. It is used to provide a stable pathway for device delivery, ensuring precision and safety during interventional procedures. The catheter's design allows it to navigate the vascular system with minimal trauma to the vessel walls.
Clinical Applications
This device is commonly used in interventional radiology and cardiology procedures, particularly for the placement of venous stents. It is utilized in hospital settings, often in catheterization labs, where precise device placement is critical. The catheter is suitable for use in adult patients requiring venous interventions, including those with venous obstructions or other vascular conditions.
Indications for Use
The softtouch r guiding catheter is indicated for use in procedures requiring the placement of devices within the venous system. It is particularly useful for patients with conditions that necessitate venous stenting, such as venous obstructions or other vascular abnormalities.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of stents and other interventional devices. Clinicians should be familiar with catheterization techniques to ensure optimal outcomes.
Frequently Asked Questions
What is softtouch r guiding catheter used for?
It is used for guiding stents and other devices into the venous system during interventional procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of devices within the venous system, such as venous stenting.
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.