📋 FDA Reference
Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath
Scimed Life Systems
Summary: The Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath is a catheter used primarily in venous stenting procedures. It is utilized by interventional radiologists and cardiologists to facilitate the placement of stents in venous systems.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K940545 ↗
Decision Date ?
May 6, 1994
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath was cleared through the FDA 510(k) pathway on May 6, 1994. Manufactured by Scimed Life Systems, it is classified as a Class 2 medical device.
What It Is
The Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath is a guiding catheter designed to assist in the placement of stents within the venous system. It features a large lumen to accommodate various guidewires and devices, enhancing the precision and ease of stent deployment. The catheter's flexible design allows for navigation through complex vascular anatomy, making it a valuable tool in interventional procedures.
FDA-Cleared Indications
- Use as a percutaneous catheter to provide guidance and support for the introduction of interventional devices during vascular procedures.
- The available FDA record identifies the device under product code DQY, Catheter, Percutaneous, without providing a more specific indication in the supplied summary.
Clinical Applications
- Percutaneous catheter-based procedures requiring a guiding catheter.
- Providing a pathway and support for guidewires or other compatible interventional devices.
- Venous interventions in which a large-lumen guiding catheter is needed, including selected venous stenting procedures when consistent with the device labeling and compatible equipment.
Practical Considerations
- The catheter is identified as 10 French, so the access sheath, guidewire, stent, and other devices must be appropriately sized and compatible.
- Flexible guiding catheters should be advanced under appropriate imaging guidance and handled carefully to reduce the risk of vessel injury, dissection, perforation, or thrombosis.
- The supplied FDA record does not state MRI safety or MR-conditional labeling. MRI use should be avoided unless the device labeling provides specific conditions.
- Patient anatomy, access-site size, vessel diameter, tortuosity, thrombosis, and contraindications to catheter-based intervention should be assessed before use.
- The device is intended for single-procedure use unless current manufacturer labeling specifically states otherwise; resterilization or reuse should not be assumed.
Procedures that use this device
Frequently Asked Questions
What is the Scimed 10 Fr Large Lumen Triguide-Flex Guid Cath used for?
It is used for guiding the placement of stents in 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 venous stenting procedures to treat venous obstructions or stenosis.
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.