đź“Š Evidence-Based Reference
percutaneous catheters
Micor
Summary: Percutaneous catheters by Micor are used for minimally invasive procedures such as venous stenting. Key evidence suggests effectiveness in various clinical scenarios, including traumatic hemothorax management.
FDA Clearance Information
Pathway
510K
Number
K860339 ↗
Decision Date
March 31, 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 March 31, 1986. They are classified as Class 2 medical devices.
What It Is
Percutaneous catheters are flexible tubes inserted through the skin to access veins or other body cavities. They are used for procedures like venous stenting and fluid drainage, providing a minimally invasive alternative to open surgery.
Clinical Applications
Commonly used in scenarios such as venous stenting, management of traumatic hemothorax, and delivery of parenteral nutrition in neonates. They offer a less invasive option for accessing internal body structures.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective cohorts, and retrospective analyses, spanning from 2016 to 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, with comparable outcomes to larger chest tubes. They are also used successfully for local anesthetic infusion in postoperative pain control and for parenteral nutrition delivery in neonates.
Safety Profile
Reported complications include potential for infection and catheter-related thrombosis, as noted in studies involving central venous access. However, the overall safety profile is favorable when used according to guidelines.
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 optimize usage protocols across different patient populations.
Frequently Asked Questions
What are the clinical indications for percutaneous catheters?
Indications include venous stenting, management of traumatic hemothorax, and delivery of parenteral nutrition in neonates.
What outcomes have been reported in clinical studies?
Studies report effective management of traumatic hemothorax and successful use in postoperative pain control and neonatal nutrition.
What complications have been reported?
Safety data indicate risks of infection and thrombosis, but these are generally manageable with proper technique.
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.