📊 Evidence-Based Reference
Infusion Catheter
Target Therapeutics
Summary: The infusion catheter by Target Therapeutics is a medical device cleared by the FDA for clinical use. It is primarily used for venous-stent applications. Key evidence includes studies on its efficacy and safety in various clinical scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K853997 ↗
Decision Date ?
November 5, 1985
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The infusion catheter was cleared through the FDA 510(k) pathway on November 5, 1985. It is manufactured by Target Therapeutics and classified as a Class 2 device.
What It Is
The infusion catheter is a device designed to deliver fluids directly into the venous system. It is used in clinical settings for procedures requiring precise fluid administration, such as venous-stent applications.
FDA-Cleared Indications
- Percutaneous catheter placement for the introduction of fluids or medications into the vascular system, consistent with the product category.
- Use in procedures requiring controlled intravascular infusion when the catheter and its labeling are appropriate for the intended vessel and therapy.
Clinical Applications
- Delivering contrast material or other fluids during image-guided vascular procedures.
- Infusing medications or therapeutic solutions into a blood vessel during a catheter-based procedure.
- Providing catheter access for selected venous interventions when the device labeling, size, and compatibility are appropriate.
Reported off-label uses
- Selective infusion during catheter-directed thrombolysis for deep vein thrombosis.
- Infusion support during endovascular venous stent procedures.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials and systematic reviews, published between 2023 and 2025. These studies explore various aspects of infusion catheter use, including efficacy and safety.
Reported Outcomes
Published studies report that infusion catheters are effective in maintaining open venous access and delivering medications with precision. They have been compared to other analgesic delivery methods, showing favorable outcomes in pain management and reduced morphine consumption.
Safety Profile
Reported complications include catheter occlusion and phlebitis, as noted in studies examining the effects of different infusion techniques. The low-speed continuous infusion method has been suggested to mitigate some of these risks.
Evidence Limitations
Current evidence is limited by the variability in study designs and the relatively small sample sizes in some trials. Further research is needed to explore long-term outcomes and optimize infusion techniques.
Practical Considerations
- The available record does not provide the catheter's French sizes, working length, lumen configuration, maximum pressure, or guidewire compatibility; clinicians should verify the original labeling before use.
- Use sterile technique and confirm compatibility with the infusion fluid, medication, contrast agent, guidewire, sheath, and other procedural equipment.
- MRI safety is not established from the supplied FDA record. Confirm the exact model and current manufacturer MRI labeling before an MRI examination.
- Potential complications include bleeding, infection, vessel injury, thrombosis, embolization, catheter malposition, leakage, and loss of catheter integrity.
- Avoid use when the intended vessel, infusion solution, patient anatomy, or clinical indication is incompatible with the device labeling or when risks of percutaneous vascular access outweigh benefits.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for infusion catheter?
The infusion catheter is indicated for use in venous-stent applications and other scenarios requiring precise fluid delivery.
What outcomes have been reported in clinical studies?
Studies have reported effective pain management and reduced morphine consumption when using infusion catheters compared to other methods.
What complications have been reported?
Safety data indicate complications such as catheter occlusion and phlebitis, with some techniques potentially reducing these risks.
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.