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percutaneous catheter insertion tray
American Pharmaseal Div. Ahsc
Summary: The percutaneous catheter insertion tray by American Pharmaseal Div. Ahsc is used for venous stent procedures. Cleared by FDA in 1983, it is supported by two studies focusing on device placement techniques.
FDA Clearance Information
Pathway
510K
Number
K831729 ↗
Decision Date
July 18, 1983
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The percutaneous catheter insertion tray was cleared through the FDA 510(k) pathway on July 18, 1983. It is manufactured by American Pharmaseal Div. Ahsc and classified as a Class 2 device.
What It Is
The percutaneous catheter insertion tray is a medical device used for the insertion of catheters into the venous system. It facilitates the placement of venous stents and is intended for use in procedures requiring vascular access.
Clinical Applications
This device is commonly used in procedures involving venous stent placements, particularly in radiological and endoscopic settings. It is essential for clinicians requiring reliable vascular access for therapeutic interventions.
Evidence Summary
The available literature includes two studies, one from 2017 and another from 2010, focusing on device placement techniques. These studies encompass various methodologies including prospective and retrospective analyses.
Reported Outcomes
Published studies report on the effectiveness of different catheter retention methods, such as balloon vs. loop retention, in maintaining device placement. The studies highlight the procedural success and potential benefits of using percutaneous techniques for catheter insertion.
Safety Profile
Reported complications include device dislodgement and infection risks associated with catheter placement. The studies emphasize the importance of technique in minimizing adverse events.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on specific procedural techniques. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for percutaneous catheter insertion tray?
The device is indicated for use in procedures requiring venous access, such as the placement of venous stents.
What outcomes have been reported in clinical studies?
Studies have reported on the effectiveness of catheter retention methods and procedural success in maintaining device placement.
What complications have been reported?
Safety data indicate risks of device dislodgement and infection, emphasizing the need for careful technique.
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.