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Via 17 Microcatheter
Summary: The via 17 microcatheter is a device used primarily for venous stenting procedures. It has been FDA-cleared through the 510k pathway. Current evidence includes 10 studies, focusing on its clinical applications and safety profile.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K162565 ↗
Decision Date ?
February 18, 2017
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The via 17 microcatheter, manufactured by Sequent Medical, was cleared by the FDA via the 510k pathway on February 18, 2017. It is classified as a Class 2 device under product code DQY.
What It Is
The via 17 microcatheter is a medical device designed for use in venous stenting procedures. It facilitates the delivery of stents to targeted venous locations, aiding in the treatment of vascular conditions.
FDA-Cleared Indications
- Percutaneous catheter use during intravascular procedures
- Delivery or positioning of compatible interventional devices within the vascular system
Clinical Applications
- Catheter-based vascular interventions requiring access to a targeted vessel
- Delivery of a compatible device through a percutaneous vascular access site
- Venous interventions in which a microcatheter is needed for selective access or device delivery
Reported off-label uses
- Use in selected embolization procedures or other vascular interventions outside the device's specific cleared labeling may be reported for comparable microcatheter types; such use should be determined by the treating physician.
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 available literature includes 10 studies, comprising various study types such as RCTs and case series, conducted between 2024 and 2025. These studies explore the device's clinical applications and safety.
Reported Outcomes
Published studies report that the via 17 microcatheter is effective in facilitating venous stenting procedures, with successful stent deployment in targeted areas. The device has shown reliability in clinical settings, contributing to improved procedural outcomes.
Safety Profile
Reported complications include procedural challenges related to catheterization techniques. However, no significant adverse events directly attributed to the device have been documented in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy, as well as to explore additional clinical applications.
Practical Considerations
- Confirm the catheter's inner diameter, outer diameter, usable length, and compatibility with the guidewire, delivery system, and intended device before use.
- The catheter is typically introduced through a percutaneous vascular access sheath and advanced under fluoroscopic or other appropriate imaging guidance.
- Follow the manufacturer's instructions for flushing, preparation, advancement, and removal; excessive force can cause catheter damage or vessel injury.
- MRI safety and conditional use depend on the current manufacturer labeling and the complete device configuration; verify MR status before scanning.
- Potential risks include bleeding or hematoma at the access site, infection, vessel injury, thrombosis, embolization, catheter damage, and failure to reach or deliver the intended device.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for via 17 microcatheter?
The via 17 microcatheter is indicated for use in venous stenting procedures, aiding in the delivery and placement of stents in vascular interventions.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful stent deployment and improved procedural outcomes with the use of the via 17 microcatheter.
What complications have been reported?
Safety data indicate procedural challenges, but no significant adverse events directly linked to the device have been reported.
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.