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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
510K
Number
K853997 ↗
Decision Date
November 5, 1985
Product Code
DQY
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.
Clinical Applications
Infusion catheters are commonly used in scenarios requiring controlled fluid delivery, such as during surgeries or for administering medications directly into the bloodstream. They are essential in managing conditions that require precise fluid management.
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.
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.