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t series vessel tips
Akcess Medical Products
Summary: The t series vessel tips by Akcess Medical Products are portal-vein devices cleared by the FDA for clinical use. Key evidence highlights their application in procedures involving portal vein access.
FDA Clearance Information
Pathway
510K
Number
K893438 ↗
Decision Date
June 8, 1989
Product Code
FKW
Device Class
Class 2
Evidence
0 studies
The t series vessel tips were cleared by the FDA via the 510(k) pathway on June 8, 1989. Manufactured by Akcess Medical Products, they are classified as Class 2 devices under product code FKW.
What It Is
The t series vessel tips are medical devices designed for use in portal vein procedures. They facilitate access to the portal vein, aiding in various diagnostic and therapeutic interventions.
Clinical Applications
These devices are commonly used in procedures requiring portal vein access, such as transjugular intrahepatic portosystemic shunt (TIPS) placements and other interventional radiology applications.
Evidence Summary
The available literature includes 10 studies, with a mix of retrospective and narrative reviews, spanning from 2019 to 2025. These studies explore various clinical applications and outcomes associated with the device.
Reported Outcomes
Published studies report outcomes related to hepatic encephalopathy, acute liver failure, and pulmonary hypertension in the context of TIPS procedures. The device has been associated with effective portal vein access in these scenarios.
Safety Profile
Reported complications include potential infections related to the use of the device in extracorporeal membrane oxygenation (ECMO) settings. Safety data specific to the t series vessel tips in portal vein applications is limited.
Evidence Limitations
The evidence base is limited by a lack of large-scale, prospective studies specifically evaluating the t series vessel tips. Further research is needed to better understand long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for t series vessel tips?
The clinical indications for t series vessel tips include procedures requiring portal vein access, such as TIPS placements.
What outcomes have been reported in clinical studies?
Studies have reported outcomes related to hepatic encephalopathy, acute liver failure, and pulmonary hypertension in the context of TIPS procedures.
What complications have been reported?
Reported complications include potential infections in ECMO settings, though specific safety data for portal vein applications 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.