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right atrial catheter kits
Akcess Medical Products
Summary: Right atrial catheter kits by Akcess Medical Products are used for venous access in clinical settings. Key evidence highlights the importance of correct guidewire length to prevent complications.
FDA Clearance Information
Pathway
510K
Number
K920331 ↗
Decision Date
April 22, 1992
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The right atrial catheter kits by Akcess Medical Products were cleared by the FDA via the 510(k) pathway on April 22, 1992. They are classified as Class 2 devices.
What It Is
Right atrial catheter kits are medical devices used for accessing the right atrium through venous routes. They are designed to facilitate the diagnosis and treatment of conditions requiring central venous access.
Clinical Applications
These kits are commonly used in scenarios requiring central venous access, such as the management of venous air emboli in neurosurgical patients. They are also used in procedures where precise catheter placement is critical.
Evidence Summary
The available literature includes a mix of study types, with a total of 5 studies ranging from 1999 to 2000. These studies explore various aspects of catheter placement and associated outcomes.
Reported Outcomes
Published studies report challenges in achieving optimal catheter positioning using ECG-based methods, particularly with certain catheterization kits. The studies highlight the need for precise guidewire measurements to ensure effective catheter placement.
Safety Profile
Reported complications include difficulties in catheter positioning, which can lead to suboptimal treatment outcomes. The studies emphasize the importance of accurate guidewire length to minimize risks.
Evidence Limitations
The evidence is limited by the small number of studies and the narrow date range. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for right atrial catheter kits?
Right atrial catheter kits are indicated for central venous access, particularly in procedures requiring precise catheter placement, such as the management of venous air emboli.
What outcomes have been reported in clinical studies?
Studies report challenges in catheter positioning using ECG-based methods, emphasizing the need for accurate guidewire measurements.
What complications have been reported?
Safety data indicate complications related to catheter positioning, highlighting the importance of correct guidewire length to prevent adverse outcomes.
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.