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Right Atrial Catheters
Akcess Medical Products
Summary: Right atrial catheters by Akcess Medical Products are used for central venous access. FDA cleared via 510k in 1991. Studies highlight their role in managing thrombi and providing long-term vascular access.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K911333 ↗
Decision Date ?
September 23, 1991
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The right atrial catheters by Akcess Medical Products were cleared by the FDA through the 510k pathway on September 23, 1991. They are classified as Class 2 devices under product code DQY.
What It Is
Right atrial catheters are medical devices designed for central venous access, facilitating the administration of medications, fluids, and other therapies directly into the right atrium. They are commonly used in patients requiring long-term vascular access.
FDA-Cleared Indications
- Establish central venous access for administration of medications, fluids, nutrition, blood products, or other prescribed therapies.
- Provide reliable venous access for patients who require prolonged or repeated intravenous treatment.
- Use as part of extracorporeal treatment circuits when central venous access is required.
Clinical Applications
- Long-term intravenous therapy, including chemotherapy and parenteral nutrition.
- Central venous access for hemodialysis or other extracorporeal therapies.
- Access for extracorporeal photopheresis and other specialized blood-processing treatments.
- Administration of medications, fluids, nutrition, or blood products through central venous access.
Reported off-label uses
- Central venous access for selected complex endovascular procedures when the catheter configuration and clinical requirements are appropriate.
- Central venous pressure monitoring or right-heart access in selected clinical settings, when specifically planned by the treating team.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 15 studies, encompassing randomized controlled trials, prospective and retrospective studies, and case series. The studies span from 1994 to 2019, providing a comprehensive view of the device's clinical applications and outcomes.
Reported Outcomes
Published studies report that right atrial catheters are effective in providing reliable long-term venous access. They are associated with successful management of thrombi and are crucial in procedures like extracorporeal photopheresis. The use of ECG for catheter positioning has been shown to enhance placement accuracy.
Safety Profile
Reported complications include the development of right atrial thrombi, particularly in patients with indwelling catheters. The incidence of thrombi is less compared to left atrial thrombi but remains a significant concern.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term safety and efficacy, as well as to optimize catheter design and placement techniques.
Practical Considerations
- Catheter diameter, length, lumen configuration, and tip design must match the intended therapy, access vessel, flow requirements, and patient anatomy.
- Placement generally requires sterile technique and imaging guidance, such as fluoroscopy or ultrasound, to confirm the access route and catheter-tip position.
- The device must be compatible with the prescribed infusates, pressure-injection requirements, extracorporeal circuit, and any other connected equipment.
- MRI safety is model-specific; check the current manufacturer labeling before an MRI examination rather than assuming the catheter is MR Safe or MR Conditional.
- Potential complications include infection, bleeding, thrombosis, vessel injury, arrhythmia, malposition, catheter fracture, air embolism, and malfunction. Contraindications and precautions depend on the patient's anatomy, infection or bleeding risk, and the planned therapy.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for right atrial catheters?
Right atrial catheters are indicated for central venous access in patients requiring long-term intravenous therapy, such as chemotherapy, parenteral nutrition, and hemodialysis.
What outcomes have been reported in clinical studies?
Studies report effective long-term venous access and successful management of thrombi. ECG-guided placement improves accuracy.
What complications have been reported?
Safety data indicate the development of right atrial thrombi as a notable complication, particularly with indwelling catheters.
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.