đź“Š Evidence-Based Reference
arterial catheter
Haolang Medical U
Summary: An arterial catheter is used for continuous blood pressure monitoring and blood sampling in critically ill patients. Key evidence highlights its role in intensive care settings and associated complications.
FDA Clearance Information
Pathway
510K
Number
K201726 ↗
Decision Date
July 7, 2021
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The arterial catheter by Haolang Medical U was cleared via the FDA 510(k) pathway on July 7, 2021. It is classified as a Class 2 medical device.
What It Is
An arterial catheter is a medical device inserted into an artery for direct blood pressure monitoring and blood sampling. It is primarily used in intensive care units for critically ill patients.
Clinical Applications
Arterial catheters are commonly used in intensive care settings for continuous hemodynamic monitoring and frequent blood sampling. They are essential in managing patients with shock or undergoing major surgery.
Evidence Summary
The literature includes 15 studies, comprising RCTs, case reports, and systematic reviews, published between 2023 and 2025. These studies explore the efficacy and safety of arterial catheters in various clinical settings.
Reported Outcomes
Published studies report that arterial catheters are effective for continuous blood pressure monitoring and blood sampling in intensive care. They are crucial in managing hemodynamic instability and ensuring accurate blood pressure readings.
Safety Profile
Reported complications include catheter-related infections, arterial occlusion, and catheter retention. These issues highlight the need for careful monitoring and management of arterial catheters in clinical practice.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to explore long-term outcomes and optimize catheter design to reduce complications.
Frequently Asked Questions
What are the clinical indications for arterial catheters?
Arterial catheters are indicated for continuous blood pressure monitoring and blood sampling in critically ill patients, particularly in intensive care settings.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective blood pressure monitoring and improved hemodynamic management in patients with arterial catheters.
What complications have been reported?
Safety data from evidence indicate complications such as infections, arterial occlusion, and catheter retention.
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.