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venture 038 catheter
Vascular Solutions
Summary: The Venture 038 Catheter by Vascular Solutions is a device used in venous stenting procedures. It was FDA cleared via the 510k pathway in 2017. Current evidence includes two studies, though neither directly addresses the catheter's efficacy or safety.
FDA Clearance Information
Pathway
510K
Number
K171335 ↗
Decision Date
June 7, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Venture 038 Catheter was cleared by the FDA through the 510k pathway on June 7, 2017. It is manufactured by Vascular Solutions and classified as a Class 2 device under product code DQY.
What It Is
The Venture 038 Catheter is a medical device designed for use in venous stenting procedures. It facilitates the delivery of stents to targeted venous locations, aiding in the treatment of venous obstructions.
Clinical Applications
This catheter is commonly used in procedures requiring precise placement of venous stents, particularly in cases of venous stenosis or occlusion. It is utilized in interventional radiology and vascular surgery settings.
Evidence Summary
The available literature includes two studies, neither of which directly evaluates the Venture 038 Catheter. The studies, published in 2023 and 2024, focus on unrelated medical topics, indicating a gap in specific evidence for this device.
Reported Outcomes
Published studies report no specific outcomes related to the Venture 038 Catheter, as the available studies do not evaluate this device directly. Further research is needed to establish efficacy outcomes.
Safety Profile
Reported complications include no specific safety data for the Venture 038 Catheter, as the available studies do not address this device. Safety profiles remain undocumented in the current literature.
Evidence Limitations
The primary limitation is the lack of direct evidence evaluating the Venture 038 Catheter. Existing studies do not provide data on its efficacy or safety, highlighting the need for targeted research in this area.
Frequently Asked Questions
What are the clinical indications for Venture 038 Catheter?
The Venture 038 Catheter is indicated for use in venous stenting procedures, particularly in cases of venous stenosis or occlusion.
What outcomes have been reported in clinical studies?
No specific outcomes have been reported for the Venture 038 Catheter, as current studies do not evaluate this device.
What complications have been reported?
No complications have been reported for the Venture 038 Catheter, as existing studies do not address this device.
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.