đź“Š Evidence-Based Reference
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Medtronic
Summary: The c320lbb delivery system by Medtronic is a venous stent delivery device, primarily used for venous interventions. Key evidence includes FDA clearance and linked studies, though specific outcomes and safety data are limited.
FDA Clearance Information
Pathway
510K
Number
K253409 ↗
Decision Date
December 19, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The c320lbb delivery system was cleared via the FDA 510(k) pathway on December 19, 2025. Manufactured by Medtronic, it is classified as a Class 2 device under product code DQY.
What It Is
The c320lbb delivery system is a medical device designed for the delivery of venous stents. It is used in clinical settings to facilitate the placement of stents within venous structures, aiding in the treatment of venous obstructions.
Clinical Applications
This device is commonly used in procedures requiring the placement of stents in venous pathways, such as in cases of venous insufficiency or obstruction. It is utilized by interventional radiologists and vascular surgeons.
Evidence Summary
The available literature includes 10 studies, with a mix of study types such as RCTs and case series, spanning from 1990 to 2023. However, specific data on the c320lbb delivery system is sparse.
Reported Outcomes
Published studies report limited direct outcomes related to the c320lbb delivery system. The evidence primarily focuses on general delivery systems and their impact on procedural success and patient recovery.
Safety Profile
Reported complications include general risks associated with venous stent placement, such as thrombosis and infection. Specific safety data for the c320lbb delivery system is not detailed in the provided studies.
Evidence Limitations
The evidence lacks specific data on the c320lbb delivery system, with most studies focusing on broader categories of delivery systems. Further research is needed to evaluate device-specific outcomes and safety.
Frequently Asked Questions
What are the clinical indications for c320lbb delivery system?
The c320lbb delivery system is indicated for the delivery of venous stents in cases of venous obstruction or insufficiency.
What outcomes have been reported in clinical studies?
Specific outcomes for the c320lbb delivery system are not detailed, but general delivery systems show procedural success and improved venous flow.
What complications have been reported?
Safety data indicates risks such as thrombosis and infection, though specific data for the c320lbb delivery system 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.