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percutaneous catheters
Micor
Summary: Percutaneous catheters by Micor are used for minimally invasive procedures, primarily in venous-stent applications. Key evidence highlights their efficacy in various clinical scenarios, including trauma and dialysis.
FDA Clearance Information
Pathway
510K
Number
K861008 ↗
Decision Date
April 29, 1986
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The percutaneous catheters by Micor were cleared through the FDA 510(k) pathway on April 29, 1986. They are classified as Class 2 devices under product code DQY.
What It Is
Percutaneous catheters are medical devices designed for minimally invasive access to the vascular system. They are used to facilitate procedures such as venous stenting and fluid drainage.
Clinical Applications
Commonly used in scenarios requiring vascular access, such as in the management of traumatic hemothorax or for dialysis. They provide a less invasive alternative to traditional surgical methods.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective, and retrospective studies, published between 2016 and 2022. These studies evaluate the efficacy and safety of percutaneous catheters in various clinical settings.
Reported Outcomes
Published studies report that percutaneous catheters are effective in managing traumatic hemothorax and facilitating dialysis. They are shown to be as effective as larger chest tubes in certain trauma cases and provide reliable access for parenteral nutrition in neonates.
Safety Profile
Reported complications include potential for infection and catheter-related thrombosis. However, studies indicate that these risks are comparable to those associated with traditional catheterization methods.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some trials. Further research is needed to establish long-term outcomes and to compare efficacy across different patient populations.
Frequently Asked Questions
What are the clinical indications for percutaneous catheters?
Percutaneous catheters are indicated for use in venous-stenting procedures and for providing vascular access in trauma and dialysis cases.
What outcomes have been reported in clinical studies?
Studies report that percutaneous catheters are effective in managing traumatic hemothorax and in providing access for dialysis, with outcomes comparable to traditional methods.
What complications have been reported?
Safety data indicate potential complications such as infection and thrombosis, similar to those seen with other catheterization techniques.
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.