📊 Evidence-Based Reference
Catheter Arterial Line
Namic
Summary: The Namic catheter arterial line is used for continuous blood pressure monitoring and blood sampling. Key evidence highlights its role in critical care settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K790083 ↗
Decision Date ?
January 25, 1979
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Namic catheter arterial line was cleared via the FDA 510(k) pathway on January 25, 1979. It is manufactured by Namic and classified as a Class 2 device.
What It Is
The catheter arterial line is a medical device designed for continuous invasive blood pressure monitoring and arterial blood sampling. It is primarily used in critical care and surgical settings.
FDA-Cleared Indications
- Percutaneous catheterization of an artery for direct measurement of arterial blood pressure.
- Percutaneous arterial access for withdrawal of blood samples.
- Use when continuous invasive arterial pressure monitoring is clinically indicated.
Clinical Applications
- Continuous arterial blood pressure monitoring in intensive care.
- Continuous arterial pressure monitoring during major surgery.
- Repeated arterial blood sampling without repeated arterial needle punctures.
- Hemodynamic monitoring in patients requiring close blood pressure assessment.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and systematic reviews, with publication years ranging from 2020 to 2025.
Reported Outcomes
Published studies report that the catheter arterial line is effective in providing continuous blood pressure monitoring and facilitating blood sampling in critically ill patients. It is a reliable tool in perioperative and intensive care settings.
Safety Profile
Reported complications include potential for infection and thrombosis, as highlighted in systematic reviews. Proper securement and dressing techniques are crucial to minimize these risks.
Evidence Limitations
Evidence gaps include a lack of large-scale, long-term studies on the device's efficacy and safety. Further research is needed to optimize securement techniques and reduce complication rates.
Practical Considerations
- The catheter is placed through the skin into an artery, commonly at the radial artery; femoral or other arterial sites may be used depending on the clinical situation.
- Use requires a compatible pressure-monitoring circuit, tubing, flush system and sampling connectors.
- Insertion and removal require attention to bleeding, distal circulation, infection prevention and catheter-site care.
- The record provided does not specify catheter sizes, exact materials, MRI labeling or maximum dwell time; consult the current manufacturer instructions for use.
- Potential contraindications or precautions include infection at the insertion site, inadequate collateral circulation, severe peripheral vascular disease, bleeding disorders and inability to safely compress the artery.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for catheter arterial line?
The catheter arterial line is indicated for continuous blood pressure monitoring and arterial blood sampling in critically ill patients.
What outcomes have been reported in clinical studies?
Studies report effective continuous blood pressure monitoring and reliable blood sampling capabilities.
What complications have been reported?
Complications such as infection and thrombosis have been reported, emphasizing the need for proper securement and dressing 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.