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long sheath or ls 70 cm long sheath or ls 80 cm long sheath or ls 90 cm
Tni Manufacturing
Summary: The long sheath by Tni Manufacturing is a medical device used primarily in venous stenting procedures. It is FDA 510k cleared and supported by 9 studies, highlighting its role in maintaining low intrarenal pressure and reducing debris during procedures.
FDA Clearance Information
Pathway
510K
Number
K152876 ↗
Decision Date
January 8, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The long sheath received FDA clearance through the 510k pathway on January 8, 2016. It is manufactured by Tni Manufacturing and classified as a Class 2 device.
What It Is
The long sheath is a medical device designed for use in venous stenting procedures. It aids in maintaining low intrarenal pressure and facilitates the removal of small debris during surgical interventions.
Clinical Applications
Commonly used in venous stenting, the long sheath is instrumental in procedures requiring precise navigation and pressure management within the venous system. It is particularly useful in maintaining procedural safety and efficacy.
Evidence Summary
The available literature includes 9 studies, with a mix of RCTs, prospective, and retrospective analyses. These studies span from 2023 to 2024, focusing on the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the long sheath is effective in maintaining low intrarenal pressure and reducing the 'snow globe' effect during procedures. It also aids in the efficient removal of small debris, enhancing procedural outcomes.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. The device's design minimizes the risk of pressure-related complications during use.
Evidence Limitations
Current evidence is limited by a lack of long-term outcome data and small sample sizes in some studies. Further research is needed to explore the device's efficacy across diverse patient populations and procedural contexts.
Frequently Asked Questions
What are the clinical indications for long sheath?
The long sheath is indicated for use in venous stenting procedures, particularly where maintaining low intrarenal pressure is critical.
What outcomes have been reported in clinical studies?
Studies report effective pressure management and debris removal, contributing to improved procedural outcomes.
What complications have been reported?
Safety data indicate minimal complications, with a favorable safety profile observed in clinical studies.
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.