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Via 21 Microcatheter
Summary: The via 21 microcatheter is a device used for endovascular procedures, primarily in venous stenting. Key evidence highlights its application in various embolization techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K150894 ↗
Decision Date ?
August 28, 2015
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The via 21 microcatheter was cleared by the FDA through the 510(k) pathway on August 28, 2015. It is manufactured by Sequent Medical and classified as a Class 2 device.
What It Is
The via 21 microcatheter is designed for use in endovascular procedures, facilitating the delivery of therapeutic agents or devices within the vascular system. It is primarily intended for venous stenting applications.
FDA-Cleared Indications
- Percutaneous catheter intended for use in the vascular system.
- Use as an accessory catheter to facilitate the delivery of therapeutic agents or devices during endovascular procedures.
Clinical Applications
- Catheter-based access to selected blood vessels during endovascular treatment.
- Delivery of therapeutic agents through a microcatheter when compatible with the procedure and the treating physician's technique.
- Delivery or positioning of compatible endovascular devices.
Reported off-label uses
- Delivery of embolic materials during selected embolization procedures.
- Selective catheterization in venous interventions, including procedures involving venous obstruction.
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 2020 and 2025. These studies explore the efficacy and safety of the microcatheter in different clinical settings.
Reported Outcomes
Published studies report the via 21 microcatheter's effectiveness in facilitating embolization procedures, with successful outcomes in maintaining vascular patency and treating vascular disorders. Specific studies highlight its role in selective lymphatic duct embolization and genicular artery embolization.
Safety Profile
Reported complications include potential risks associated with endovascular procedures, such as vascular injury or embolic events. However, the studies reviewed did not provide detailed safety data specific to the via 21 microcatheter.
Evidence Limitations
The evidence is limited by the lack of large-scale, long-term studies specifically evaluating the via 21 microcatheter. Further research is needed to establish comprehensive safety profiles and long-term efficacy.
Practical Considerations
- The available FDA record does not provide the catheter's full size range, working length, distal-tip configuration, or guidewire compatibility; these details should be confirmed in the current manufacturer labeling.
- Use requires compatible guidewires, introducers, diagnostic catheters, therapeutic agents, and devices specified by the manufacturer.
- Microcatheters require careful flushing, air removal, and manipulation under fluoroscopic imaging to reduce the risk of vessel injury, thrombosis, or unintended delivery.
- MRI safety depends on the exact device configuration and labeling. Do not assume the catheter is MR Safe or MR Conditional without reviewing the current instructions for use.
- Contraindications and warnings include inability to safely access the target vessel, severe vessel spasm or injury risk, infection at the access site, and known intolerance to materials or the intended therapeutic agent.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for via 21 microcatheter?
The via 21 microcatheter is indicated for use in endovascular procedures, particularly in venous stenting and embolization techniques.
What outcomes have been reported in clinical studies?
Studies report successful outcomes in embolization procedures, with effectiveness in maintaining vascular patency and treating vascular disorders.
What complications have been reported?
Reported complications include risks typical of endovascular procedures, such as vascular injury or embolic events, though specific data on the via 21 microcatheter is limited.
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.