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via 21 microcatheter
Sequent Medical
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 510K
Number K150894 ↗
Decision Date August 28, 2015
Product Code DQY
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.
Clinical Applications
Commonly used in procedures requiring precise delivery of embolic agents or stents, the via 21 microcatheter is utilized in treating conditions such as venous obstructions and other vascular disorders.
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.
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.