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right atrial line kit
Stanco Medical
Summary: The right atrial line kit by Stanco Medical is a Class 2 device used for venous access. It was FDA cleared via the 510k pathway. Key evidence includes studies on atrial fibrillation and venous thrombosis.
FDA Clearance Information
Pathway
510K
Number
K802287 ↗
Decision Date
November 20, 1980
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The right atrial line kit was cleared by the FDA through the 510k pathway on November 20, 1980. It is manufactured by Stanco Medical and classified as a Class 2 device.
What It Is
The right atrial line kit is designed for venous access, particularly in the right atrium. It is used in clinical settings for procedures requiring direct access to the venous system.
Clinical Applications
Commonly used in scenarios requiring venous access for monitoring or therapeutic interventions, such as in patients with atrial fibrillation or those requiring venous stenting.
Evidence Summary
The literature includes 5 studies, ranging from 2020 to 2024, covering various aspects of atrial fibrillation and venous thrombosis. Study types include RCTs, case series, and retrospective analyses.
Reported Outcomes
Published studies report on the recurrence of atrial fibrillation post-treatment and the management of venous thrombus. Evidence suggests varying success rates in treatment efficacy.
Safety Profile
Reported complications include thrombus formation and recurrence of atrial fibrillation. Safety data from studies highlight the need for careful patient selection and monitoring.
Evidence Limitations
The evidence is limited by the small number of studies directly addressing the device's use. Further research is needed to establish standardized protocols and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for right atrial line kit?
The device is indicated for venous access in procedures requiring direct access to the right atrium, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report on atrial fibrillation recurrence and thrombus management, with varying success rates.
What complications have been reported?
Safety data indicate complications such as thrombus formation and atrial fibrillation recurrence.
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.