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wire guide catheter
Lake Region Mfg.
Summary: The wire guide catheter by Lake Region Mfg. is a device cleared by the FDA for use in venous-stent procedures. Key evidence highlights its application in complex catheter exchanges and embolization techniques.
FDA Clearance Information
Pathway
510K
Number
K850829 ↗
Decision Date
June 26, 1985
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The wire guide catheter was cleared through the FDA 510(k) pathway on June 26, 1985. It is manufactured by Lake Region Mfg. and classified as a Class 2 device under product code DQY.
What It Is
The wire guide catheter is a medical device used to facilitate the placement of stents in venous procedures. It serves as a conduit for other instruments, providing support and direction during catheterization.
Clinical Applications
Commonly used in procedures requiring precise catheter placement, such as in transradial embolization of intracranial aneurysms and complex catheter exchanges in venous interventions.
Evidence Summary
The literature includes 15 studies, comprising RCTs, retrospective analyses, and case series, published between 2024 and 2025. These studies explore various techniques and applications of the wire guide catheter.
Reported Outcomes
Published studies report successful use of the wire guide catheter in complex catheter exchanges and embolization procedures. Techniques such as balloon shaft-assisted exchanges and magnetism-enhanced guide wires have shown promising results in enhancing procedural success.
Safety Profile
Reported complications include potential air embolism during catheter exchanges, which can be mitigated by specific techniques such as the catheter clamp over hydrophilic guide wire method. No major adverse events were highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale RCTs. Further research is needed to establish long-term outcomes and safety profiles across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for wire guide catheter?
The wire guide catheter is indicated for use in venous-stent procedures, including complex catheter exchanges and embolization of intracranial aneurysms.
What outcomes have been reported in clinical studies?
Studies report successful catheter exchanges and embolization procedures, with techniques enhancing procedural support and reducing complications.
What complications have been reported?
Reported complications include potential air embolism during catheter exchanges, which can be reduced with specific procedural techniques.
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.