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Onset Access Catheter System
Onset Medical
Summary: The Onset Access Catheter System is a medical device used primarily for venous stenting. It has been FDA-cleared via the 510(k) pathway. Key evidence highlights its role in reducing central line-associated bloodstream infections (CLABSI) in intensive care settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K112629 ↗
Decision Date ?
October 11, 2011
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Onset Access Catheter System was cleared by the FDA through the 510(k) pathway on October 11, 2011. It is manufactured by Onset Medical and classified as a Class 2 device.
What It Is
The Onset Access Catheter System is designed for venous access and stenting. It facilitates the placement of stents in venous structures, aiding in the management of conditions requiring venous intervention.
FDA-Cleared Indications
- A percutaneous catheter intended to provide access to blood vessels during endovascular procedures, consistent with FDA product code DQY and 21 CFR 870.1250.
Clinical Applications
- Percutaneous vascular access for an endovascular intervention
- Catheter-based access to peripheral or central veins when clinically indicated
- Delivery or exchange access during a vascular procedure, when compatible with the selected technique and equipment
Evidence Summary
The available literature includes 14 studies, with a mix of randomized controlled trials, prospective, and retrospective studies. The studies span from 2013 to 2025, focusing on various clinical outcomes and safety profiles.
Reported Outcomes
Published studies report that the Onset Access Catheter System is effective in reducing the incidence of CLABSI in pediatric and neonatal intensive care units. The device has shown promise in improving patient outcomes in venous stenting procedures.
Safety Profile
Reported complications include potential risks associated with central line placement, such as infection and thrombosis. However, the device has been associated with a reduction in CLABSI rates, indicating a favorable safety profile in intensive care settings.
Evidence Limitations
Current evidence is limited by the lack of large-scale randomized controlled trials specifically focusing on the Onset Access Catheter System. Further research is needed to explore long-term outcomes and comparative effectiveness with other venous access devices.
Practical Considerations
- The available FDA summary does not provide detailed catheter sizes, lengths, lumen configuration, guidewire compatibility, or sheath compatibility; confirm these details in the current manufacturer instructions for use.
- Use sterile technique and fluoroscopic or other appropriate imaging guidance as required by the procedure.
- Review the device labeling for contraindications, warnings, maximum injection pressure, and recommended guidewire or accessory compatibility.
- MRI safety status is not established in the supplied record; verify whether the specific model is MR Safe, MR Conditional, or MR Unsafe before MRI.
- Potential complications are typical of percutaneous vascular catheterization and may include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and device malfunction.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Onset Access Catheter System?
The device is indicated for use in venous stenting, particularly in patients at risk of central line-associated bloodstream infections.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in CLABSI rates and improved outcomes in venous stenting procedures.
What complications have been reported?
Safety data indicate potential risks such as infection and thrombosis, though the device has been associated with reduced CLABSI rates.
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.