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manan arterial catheter needle
Manan Medical Products
Summary: The Manan Arterial Catheter Needle is a medical device used for arterial access, commonly employed by clinicians in procedures requiring arterial blood sampling or monitoring. It is primarily used by healthcare professionals in critical care and surgical settings.
FDA Clearance Information
Pathway
510K
Number
K900978 ↗
Decision Date
August 23, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Manan Arterial Catheter Needle was cleared through the FDA 510k pathway on August 23, 1990. Manufactured by Manan Medical Products, it is classified as a Class 2 device under product code DQY.
What It Is
The Manan Arterial Catheter Needle is designed for arterial access, allowing clinicians to perform procedures such as arterial blood sampling and continuous blood pressure monitoring. It consists of a needle that facilitates the insertion of a catheter into an artery. This device is essential in critical care settings where accurate hemodynamic monitoring is crucial.
Clinical Applications
This device is commonly used in intensive care units and operating rooms. It is vital for patients requiring continuous blood pressure monitoring, frequent arterial blood gas analysis, or during major surgeries where hemodynamic stability needs to be closely monitored. Anesthesiologists, critical care specialists, and emergency medicine physicians frequently utilize this device.
Indications for Use
The FDA indications suggest this device is intended for patients needing arterial access for monitoring or diagnostic purposes. It is particularly useful in critically ill patients or those undergoing major surgical procedures.
Practical Considerations
The Manan Arterial Catheter Needle typically comes in various sizes to accommodate different patient anatomies and clinical needs. It is compatible with standard arterial catheters and requires aseptic technique during insertion to prevent infection.
Frequently Asked Questions
What is the Manan Arterial Catheter Needle used for?
It is used for gaining arterial access for blood sampling and continuous blood pressure monitoring.
What specialties typically use this device?
This device is commonly used by anesthesiologists, critical care specialists, and emergency medicine physicians.
What are the FDA-cleared indications?
It is indicated for arterial access in patients needing monitoring or diagnostic blood sampling, especially 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.