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isolate infusion cathetr system
Lake Region Mfg.
Summary: The isolate infusion catheter system is a device used primarily for venous stenting. Key evidence includes FDA clearance and 10 linked studies examining various clinical outcomes.
FDA Clearance Information
Pathway
510K
Number
K913517 ↗
Decision Date
November 5, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The isolate infusion catheter system was cleared by the FDA via the 510(k) pathway on November 5, 1991. It is manufactured by Lake Region Mfg. and classified as a Class 2 device.
What It Is
The isolate infusion catheter system is designed for use in venous stenting procedures. It facilitates the delivery of stents to targeted venous sites, aiding in the management of venous obstructions.
Clinical Applications
This device is commonly used in procedures requiring venous stenting, particularly in cases of venous obstructions or insufficiencies. It is utilized in interventional radiology and vascular surgery settings.
Evidence Summary
The literature includes 10 studies, with a mix of study types such as RCTs, prospective, and retrospective analyses. The studies span from 2004 to 2024, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report varied outcomes related to the use of the isolate infusion catheter system. While specific efficacy data is limited in the provided evidence, the device is generally associated with successful venous stenting procedures.
Safety Profile
Reported complications include general risks associated with catheter use, such as infection and thrombosis. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence base lacks detailed outcome measures and specific safety data related to the isolate infusion catheter system. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for isolate infusion catheter system?
The device is indicated for use in venous stenting procedures, particularly in managing venous obstructions.
What outcomes have been reported in clinical studies?
Studies report successful venous stenting, though specific efficacy data is not detailed in the provided evidence.
What complications have been reported?
Reported complications include risks typical of catheter use, such as infection and thrombosis, though specific data 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.