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universal delivery system catheter
Microvena
Summary: The universal delivery system catheter by Microvena is a device used primarily for venous stenting. It is FDA 510k cleared and supported by 15 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K900657 ↗
Decision Date
May 9, 1990
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The universal delivery system catheter was cleared by the FDA via the 510k pathway on May 9, 1990. It is manufactured by Microvena and classified as a Class 2 device.
What It Is
The universal delivery system catheter is designed for the delivery of venous stents. It facilitates the placement and deployment of stents within the venous system, aiding in the treatment of venous obstructions.
Clinical Applications
This catheter is commonly used in procedures requiring venous stenting, such as in cases of venous insufficiency or obstruction. It provides a means to deliver and deploy stents accurately within the venous anatomy.
Evidence Summary
The literature includes 15 studies, encompassing various study types. The studies range from 2023 to 2025, though specific details on outcomes and safety are not provided in the evidence.
Reported Outcomes
Published studies report limited specific outcomes related to the universal delivery system catheter. The evidence provided does not detail efficacy findings directly associated with this device.
Safety Profile
Reported complications include general risks associated with catheter use, but specific safety data for this device is not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the universal delivery system catheter. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for the universal delivery system catheter?
The clinical indications are primarily for venous stenting, as outlined in FDA documentation.
What outcomes have been reported in clinical studies?
Specific findings from the evidence are not detailed, indicating a need for further research.
What complications have been reported?
Safety data specific to this device is not detailed in the provided evidence.
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.