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respiguide delivery system
Respicardia
Summary: The Respiguide Delivery System by Respicardia is a Class 2 medical device cleared by the FDA for venous-stent applications. Key evidence includes 10 studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K130378 ↗
Decision Date
October 17, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Respiguide Delivery System was cleared via the FDA 510(k) pathway on October 17, 2013. It is manufactured by Respicardia and classified as a Class 2 device under product code DQY.
What It Is
The Respiguide Delivery System is designed for the delivery of venous stents. It is intended for use in clinical settings where venous stenting is indicated, providing a mechanism for precise stent placement.
Clinical Applications
Commonly used in procedures requiring venous stenting, the Respiguide Delivery System is applicable in scenarios involving venous obstruction or insufficiency, aiding in the restoration of venous flow.
Evidence Summary
The available literature includes 10 studies, though specific study types and outcomes are not detailed. The studies span from 2017 to 2023, indicating ongoing research interest.
Reported Outcomes
Published studies report limited specific outcomes related to the Respiguide Delivery System. The evidence provided does not include detailed efficacy findings, highlighting a gap in comprehensive outcome data.
Safety Profile
Reported complications include limited safety data from the evidence provided. The studies do not specify adverse events directly related to the Respiguide Delivery System, indicating a need for more focused safety research.
Evidence Limitations
The evidence lacks detailed outcomes and safety data specific to the Respiguide Delivery System. Further research is needed to establish comprehensive efficacy and safety profiles, as well as to explore long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Respiguide Delivery System?
The Respiguide Delivery System is indicated for use in venous-stent applications.
What outcomes have been reported in clinical studies?
Specific outcomes related to the Respiguide Delivery System are not detailed in the provided evidence.
What complications have been reported?
The evidence does not specify complications directly related to the Respiguide Delivery System.
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.