📊 Evidence-Based Reference
Guide Catheters and Accessories
Thomas Medical Products
Summary: Guide catheters and accessories by Thomas Medical Products are used in venous-stent procedures. FDA-cleared under 510k pathway. Evidence includes 15 studies focusing on clinical outcomes and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K101015 ↗
Decision Date ?
September 23, 2010
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The guide catheters and accessories by Thomas Medical Products were cleared by the FDA under the 510k pathway on September 23, 2010. They are classified as Class 2 devices.
What It Is
Guide catheters and accessories are medical devices used to facilitate the placement of stents in venous procedures. They are designed to provide access and support for interventional tools during stenting.
FDA-Cleared Indications
- Used percutaneously to provide catheter access and support for the placement of interventional devices.
- Intended for use in vascular procedures in accordance with the specific cleared device labeling.
- Classified under FDA product code DQY: percutaneous catheter, 21 CFR 870.1250.
Clinical Applications
- Providing access and support during venous-stent placement.
- Facilitating catheter navigation through the venous system.
- Supporting the delivery of interventional tools during treatment of venous obstruction.
- Assisting vascular procedures performed under fluoroscopic or other intraprocedural imaging guidance.
Evidence Summary
The available literature includes 15 studies, encompassing various study types such as RCTs, prospective, and retrospective analyses. The studies span from 2020 to 2024, providing insights into clinical outcomes and safety.
Reported Outcomes
Published studies report that guide catheters and accessories are effective in facilitating venous stenting procedures. They have been shown to improve procedural success rates and patient outcomes in complex cases involving venous obstructions.
Safety Profile
Reported complications include potential risks associated with catheter navigation, such as vascular injury or dissection. However, the overall safety profile is favorable with proper technique and device handling.
Evidence Limitations
The evidence is limited by the variability in study designs and sample sizes. Further research is needed to standardize outcome measures and assess long-term safety and efficacy in diverse patient populations.
Practical Considerations
- The appropriate catheter size, length, tip configuration, and accessories depend on the access site, target vessel, anatomy, and interventional device being delivered.
- Compatibility with guidewires, stents, balloons, contrast agents, and other devices should be confirmed before use.
- These devices are typically handled using sterile technique and advanced under fluoroscopic or other imaging guidance.
- MRI safety is device-specific; the exact product labeling should be checked before MRI, and the device should not be assumed to be MR safe or MR conditional.
- Potential complications include vascular injury, bleeding at the access site, infection, thrombosis, embolization, vessel spasm, contrast reaction, and catheter damage or entrapment.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for guide catheters and accessories?
Guide catheters and accessories are indicated for use in venous-stent procedures, particularly in cases requiring enhanced catheter navigation and support.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural success rates and patient outcomes in venous stenting procedures using these devices.
What complications have been reported?
Safety data indicate potential complications such as vascular injury or dissection, though these are mitigated with proper device handling.
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.