đź“‹ FDA Reference
softouch r guiding catheter w bumper tip
Mallinckrodt Medical
Summary: The softouch r guiding catheter with bumper tip is a medical device used primarily in vascular procedures to guide stents or other instruments into place. It is typically used by interventional radiologists or cardiologists.
FDA Clearance Information
Pathway
510K
Number
K912191 ↗
Decision Date
July 30, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The softouch r guiding catheter w bumper tip, manufactured by Mallinckrodt Medical, received FDA clearance via the 510k pathway on July 30, 1991. It is classified as a Class 2 device under product code DQY.
What It Is
The softouch r guiding catheter w bumper tip is a specialized catheter designed to assist in the placement of stents or other devices within the vascular system. It features a bumper tip to minimize trauma to vessel walls during navigation. The catheter provides a stable and flexible conduit for delivering therapeutic devices to target sites within the venous system.
Clinical Applications
This guiding catheter is commonly used in interventional radiology and cardiology procedures, particularly those involving the placement of venous stents. It is suitable for use in hospital settings, especially in catheterization labs. The device is used in patients requiring vascular interventions, such as those with venous obstructions or anomalies.
Indications for Use
The device is indicated for use in procedures that require the guidance of other instruments or devices into the venous system. It is particularly useful for patients needing stent placement to address venous blockages or structural issues.
Practical Considerations
The softouch r guiding catheter is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard interventional equipment, and clinicians should be familiar with catheter navigation techniques to optimize its use.
Frequently Asked Questions
What is the softouch r guiding catheter w bumper tip used for?
It is used to guide stents or other devices into the venous system during vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for guiding instruments or devices into the venous system, particularly for stent placement.
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.