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profuse infusion system
Lake Region Mfg.
Summary: The Profuse Infusion System by Lake Region Mfg. is a Class 2 medical device cleared by the FDA for use in venous stents. Key evidence includes studies on coagulation and cardiovascular effects.
FDA Clearance Information
Pathway
510K
Number
K912877 ↗
Decision Date
September 23, 1991
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Profuse Infusion System was cleared by the FDA via the 510(k) pathway on September 23, 1991. It is manufactured by Lake Region Mfg. and classified as a Class 2 device.
What It Is
The Profuse Infusion System is designed for the controlled infusion of fluids in clinical settings, particularly in procedures involving venous stents. It ensures precise delivery of therapeutic agents.
Clinical Applications
Commonly used in procedures requiring venous stenting, the device is integral in managing fluid delivery in cardiovascular and coagulation-related interventions.
Evidence Summary
The literature includes 11 studies, comprising various study types such as RCTs and case series, conducted between 1990 and 2011. These studies explore the device's effects on coagulation and cardiovascular systems.
Reported Outcomes
Published studies report that the Profuse Infusion System effectively manages fluid delivery in cardiovascular and coagulation contexts. Specific findings include its role in systemic infusion effects and cardiovascular responses.
Safety Profile
Reported complications include potential cardiovascular and respiratory effects, as observed in studies involving ketamine infusions and systemic nucleotide administration.
Evidence Limitations
The evidence is limited by the diversity of study designs and the specific focus on certain physiological responses. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for the Profuse Infusion System?
The device is indicated for use in venous stenting procedures, particularly where precise fluid infusion is required.
What outcomes have been reported in clinical studies?
Studies report effective fluid management in cardiovascular and coagulation contexts, with specific outcomes related to systemic infusion effects.
What complications have been reported?
Safety data indicate potential cardiovascular and respiratory effects, particularly in contexts involving systemic infusion of certain agents.
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.