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pharmaseal over-the needle arterial catheter sta
American Pharmaseal Div. Ahsc
Summary: The Pharmaseal Over-the-Needle Arterial Catheter STA is a Class 2 medical device used for arterial access. It is commonly used by clinicians in critical care and surgical settings for monitoring arterial blood pressure and obtaining blood samples.
FDA Clearance Information
Pathway
510K
Number
K853714 ↗
Decision Date
January 13, 1986
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Pharmaseal Over-the-Needle Arterial Catheter STA was cleared through the FDA 510k pathway on January 13, 1986. It is manufactured by American Pharmaseal Div. Ahsc and classified as a Class 2 device under product code DQY.
What It Is
The Pharmaseal Over-the-Needle Arterial Catheter STA is a medical device designed for arterial access. It consists of a catheter placed over a needle, allowing for easy insertion into an artery. This device is used to monitor arterial blood pressure continuously and to obtain arterial blood samples for analysis. Its design facilitates quick and reliable access to the arterial system, which is crucial in critical care settings.
Clinical Applications
This catheter is primarily used in intensive care units and operating rooms. It is essential for patients who require continuous blood pressure monitoring or frequent arterial blood sampling, such as those undergoing major surgery or suffering from critical illnesses. Anesthesiologists, intensivists, and critical care nurses are the primary users of this device, ensuring accurate hemodynamic monitoring and management.
Indications for Use
The device is indicated for patients needing continuous arterial blood pressure monitoring or frequent arterial blood sampling. It is particularly useful in critical care and surgical settings where precise hemodynamic management is required.
Practical Considerations
The catheter typically comes in various sizes to accommodate different patient anatomies. It is compatible with standard arterial pressure monitoring systems. Clinicians should be trained in arterial catheter insertion techniques to minimize complications such as bleeding or infection.
Frequently Asked Questions
What is the Pharmaseal Over-the-Needle Arterial Catheter STA used for?
It is used for continuous arterial blood pressure monitoring and obtaining arterial blood samples.
What specialties typically use this device?
Anesthesiology, critical care, and surgery are the main specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for continuous arterial blood pressure monitoring and frequent arterial blood sampling in critical care and surgical settings.
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.