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arrow seldinger arterial catheterization device 18 ga arrow seldinger arterial catheterization device 20 ga arrow seldinger arterial catheterization device 22 ga arrow seldinger arterial catheterization device 24 ga
Arrow International, Inc. (Subsidiary Of Telelflex Inc.)
Summary: The Arrow Seldinger Arterial Catheterization Device is used for arterial access in clinical settings. It is FDA 510k cleared and supported by evidence from 7 studies, focusing on outcomes like vascular ultrasound abnormalities and infection rates.
FDA Clearance Information
Pathway
510K
Number
K171146 ↗
Decision Date
June 23, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Arrow Seldinger Arterial Catheterization Device was cleared via the FDA 510k pathway on June 23, 2017. It is manufactured by Arrow International, Inc., a subsidiary of Teleflex Inc., and is classified as a Class 2 device.
What It Is
The Arrow Seldinger Arterial Catheterization Device is designed for arterial access using the Seldinger technique. It is intended for use in procedures requiring arterial catheterization, providing a reliable method for accessing the arterial system.
Clinical Applications
Commonly used in perioperative settings for hemodynamic monitoring and blood gas analysis, the device is applicable in scenarios requiring precise arterial access, such as cardiac surgeries and critical care settings.
Evidence Summary
The literature includes 7 studies, comprising prospective evaluations and case series, with publication years ranging from 2000 to 2025. These studies investigate outcomes like catheter-related infections and procedural success rates.
Reported Outcomes
Published studies report outcomes such as the incidence of abnormal duplex vascular ultrasound and catheter-related infections. The device has been evaluated for its effectiveness in providing stable arterial access and its role in perioperative care.
Safety Profile
Reported complications include catheter-related infections, as highlighted in the prospective study. The evidence suggests a need for vigilance in monitoring for potential infections following catheterization.
Evidence Limitations
The evidence is limited by the small number of studies specifically addressing this device. Further research is needed to explore long-term outcomes and to compare efficacy with alternative devices.
Frequently Asked Questions
What are the clinical indications for Arrow Seldinger Arterial Catheterization Device?
The device is indicated for arterial access in clinical settings, particularly for hemodynamic monitoring and blood gas analysis.
What outcomes have been reported in clinical studies?
Studies have reported outcomes such as the incidence of abnormal duplex vascular ultrasound and catheter-related infections.
What complications have been reported?
Reported complications include catheter-related infections, as identified in the prospective study.
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.