đź“‹ FDA Reference
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 ?
510(k)
Number ?
K912199 ↗
Decision Date ?
July 30, 1991
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For percutaneous vascular catheter use during procedures that require access to and guidance within the vascular system.
- For providing a conduit or guiding pathway for the placement of other interventional devices, as specified in the device labeling.
Clinical Applications
- Percutaneous catheter-based vascular procedures in which a guiding catheter is needed.
- Guidance and delivery of compatible interventional devices during endovascular treatment.
- Use in hospital-based catheterization or interventional procedure suites by trained clinicians.
Practical Considerations
- The available FDA record does not provide detailed specifications for catheter diameter, length, tip configuration, or working-channel size; clinicians should confirm these details in the current device labeling.
- Compatibility with guidewires, stents, and other devices must be verified before use.
- The catheter should be handled with fluoroscopic or other appropriate imaging guidance and advanced by clinicians trained in percutaneous vascular access.
- MRI safety and conditional-use information are not established by the supplied FDA record; check the current labeling before an MRI examination.
- As with other intravascular catheters, potential complications include bleeding, hematoma, vessel injury, thrombosis, embolization, infection, contrast reaction, and catheter malfunction.
Procedures that use this device
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.