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right atrial catheter catalog no rac - xxx series
Intracath
Summary: The right atrial catheter by Intracath is a Class 2 medical device cleared by the FDA for venous-stent applications. Key evidence includes studies on atrial pharmacological therapies and neonatal ECMO cannula hemodynamics.
FDA Clearance Information
Pathway
510K
Number
K860699 ↗
Decision Date
April 2, 1986
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The right atrial catheter, manufactured by Intracath, was cleared through the FDA 510(k) pathway on April 2, 1986. It is classified as a Class 2 device under product code DQY.
What It Is
The right atrial catheter is designed for use in venous-stent applications, facilitating access to the right atrium for various clinical interventions. It is intended for use in procedures requiring precise catheter placement in the atrial region.
Clinical Applications
Common clinical scenarios for the right atrial catheter include its use in atrial pharmacological therapies and extracorporeal membrane oxygenation (ECMO) procedures, particularly in neonatal and congenital heart patients.
Evidence Summary
The available literature includes two studies published between 2018 and 2019. These studies encompass various methodologies, including prospective and retrospective analyses, focusing on atrial pharmacological therapies and ECMO cannula hemodynamics.
Reported Outcomes
Published studies report on the effectiveness of the right atrial catheter in facilitating atrial pharmacological therapies and improving hemodynamics in ECMO procedures. The catheter's design and placement are crucial for optimal clinical outcomes.
Safety Profile
Reported complications include challenges in catheter placement and potential hemodynamic instability during ECMO procedures. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety outcomes. Further research is needed to explore long-term efficacy and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the right atrial catheter?
The right atrial catheter is indicated for use in venous-stent applications, particularly in atrial pharmacological therapies and ECMO procedures.
What outcomes have been reported in clinical studies?
Studies report improved hemodynamics and effective drug delivery in atrial therapies, with the catheter's design playing a significant role.
What complications have been reported?
Safety data indicate potential challenges in catheter placement and hemodynamic instability during ECMO, though specific adverse events were not detailed.
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.