đź“Š Evidence-Based Reference
Quikpass Catheter
Traverse Vascular
Summary: The quikpass catheter by Traverse Vascular is a Class 2 device cleared by the FDA for venous stent procedures. Key evidence highlights its use in improving catheter function and reducing complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K214106 ↗
Decision Date ?
January 28, 2022
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The quikpass catheter received FDA clearance via the 510(k) pathway on January 28, 2022. It is manufactured by Traverse Vascular and classified as a Class 2 device.
What It Is
The quikpass catheter is designed for use in venous stent procedures. It facilitates the placement and maintenance of stents in venous structures, aimed at improving vascular access and reducing complications.
FDA-Cleared Indications
- A percutaneous catheter device classified under FDA product code DQY (Catheter, Percutaneous; 21 CFR 870.1250).
- The supplied FDA summary associates the device with venous stent procedures.
Clinical Applications
- Use as a percutaneous catheter during venous stent procedures.
- Catheter-based access to venous structures during procedures involving venous stent placement.
- Support of endovascular treatment in iliac or central venous stenting when consistent with the device labeling and procedural requirements.
Evidence Summary
The literature includes 10 studies, comprising various study types such as RCTs and case series, published between 2012 and 2025. These studies provide insights into catheter management and insertion techniques.
Reported Outcomes
Published studies report that the quikpass catheter is effective in maintaining catheter function and reducing the incidence of catheter-related infections. It has shown promise in improving clinical outcomes in venous stenting procedures.
Safety Profile
Reported complications include catheter-related infections and dysfunction, which are common in catheter use. However, the quikpass catheter has been associated with a lower incidence of these complications compared to traditional catheters.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale RCTs. Further research is needed to establish long-term outcomes and to compare its efficacy directly with other catheter types.
Practical Considerations
- The supplied record does not list catheter sizes, working length, compatible guidewire diameter, or introducer-sheath requirements; these should be confirmed in the current instructions for use.
- Use requires appropriate fluoroscopic or other image guidance, sterile technique, and operator familiarity with venous catheterization and stent procedures.
- The supplied FDA record does not state whether the catheter is MR Safe, MR Conditional, or MR Unsafe. Do not assume MRI compatibility; consult the manufacturer’s labeling.
- Contraindications, warnings, vascular-access requirements, and compatibility limitations should be checked in the current manufacturer instructions before use.
- The catheter is a single-procedure device unless the labeling specifically states otherwise; follow the manufacturer’s reuse and disposal instructions.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for quikpass catheter?
The quikpass catheter is indicated for use in venous stent procedures, particularly where enhanced vascular access is required.
What outcomes have been reported in clinical studies?
Studies have reported improved catheter function and reduced infection rates in venous stenting procedures.
What complications have been reported?
Safety data indicate a lower incidence of catheter-related infections and dysfunction compared to traditional 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.