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over the needle catheter arterial catheter needle
Argon Medical
Summary: The over the needle catheter arterial catheter needle by Argon Medical is used for arterial access. It is primarily used in procedures requiring arterial cannulation. Key evidence highlights its use in complex arterial procedures.
FDA Clearance Information
Pathway
510K
Number
K882221 ↗
Decision Date
August 12, 1988
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on August 12, 1988. It is manufactured by Argon Medical and classified as a Class 2 device.
What It Is
The over the needle catheter arterial catheter needle is designed for arterial access, facilitating procedures such as arterial cannulation. It is used in clinical settings requiring precise arterial entry.
Clinical Applications
Commonly used in scenarios requiring arterial access, such as monitoring arterial blood pressure or obtaining arterial blood samples. It is also utilized in complex arterial interventions.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials and other study types, published between 2021 and 2025. These studies explore various applications and outcomes of the device.
Reported Outcomes
Published studies report successful use of the device in complex arterial procedures, including retrograde recanalizations and dynamic needle tip positioning for arterial cannulation. Outcomes indicate improved procedural success in challenging cases.
Safety Profile
Reported complications include arterial trauma during central venous catheter insertion, as noted in incident reports. Other studies highlight the need for careful technique to minimize risks.
Evidence Limitations
Evidence gaps include limited large-scale studies directly comparing this device to alternatives. Further research is needed to establish long-term outcomes and refine safety protocols.
Frequently Asked Questions
What are the clinical indications for over the needle catheter arterial catheter needle?
The device is indicated for arterial access in procedures requiring arterial cannulation, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report successful arterial access and improved procedural success in complex cases, such as retrograde recanalizations.
What complications have been reported?
Safety data indicate potential for arterial trauma during insertion, emphasizing the importance of technique to reduce complications.
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.