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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 ?
510(k)
Number ?
K802287 ↗
Decision Date ?
November 20, 1980
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter access to the venous system.
- Access to central veins and the right atrium when required for a clinical procedure.
Clinical Applications
- Establishing central venous access for intravascular monitoring.
- Providing venous access during procedures involving the central venous system.
- Supporting catheter-based treatment or diagnostic procedures requiring access to the right atrium or central veins.
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.
Practical Considerations
- The kit should be selected with catheter dimensions and access-site requirements appropriate for the intended procedure.
- Placement generally requires sterile technique and imaging or physiologic confirmation of catheter position.
- Compatibility with guidewires, introducers, infusion systems, and other procedural equipment should be confirmed before use.
- MRI safety cannot be determined from the FDA classification or product code alone; review the current manufacturer labeling for MR Safe, MR Conditional, or MR Unsafe status.
- Potential complications of central venous catheterization include bleeding, infection, thrombosis, vascular injury, arrhythmia, and malposition.
Procedures that use this device
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.