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introducing catheter
Devices For Vascular Intervention
Summary: The introducing catheter by Devices For Vascular Intervention is a Class 2 medical device used primarily in embolization procedures. Key evidence highlights its role in renal denervation for hypertension management.
FDA Clearance Information
Pathway
510K
Number
K883933 ↗
Decision Date
December 2, 1988
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducing catheter was cleared by the FDA via the 510(k) pathway on December 2, 1988. It is manufactured by Devices For Vascular Intervention and classified as a Class 2 device.
What It Is
The introducing catheter is a medical device designed for use in vascular interventions, particularly for embolization procedures. It facilitates the introduction of other instruments or agents into the vascular system.
Clinical Applications
Commonly used in procedures such as renal denervation for hypertension management and intra-aneurysmal embolization. It is essential in scenarios requiring precise vascular access.
Evidence Summary
The literature includes 15 studies, encompassing RCTs, prospective, and retrospective analyses, published between 2012 and 2017. These studies explore various clinical applications and outcomes of the introducing catheter.
Reported Outcomes
Published studies report that the introducing catheter is effective in facilitating renal denervation, reducing hypertension in resistant cases. It also shows efficacy in embolization procedures, with angiographic results indicating complete occlusion in some cases.
Safety Profile
Reported complications include symptomatic embolism, persistent symptomatic complications, and heparinization-related risks. Some studies noted potential risks of hemorrhage associated with heparinization during procedures.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some cases. 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 introducing catheter?
The introducing catheter is indicated for use in embolization procedures and renal denervation for hypertension management.
What outcomes have been reported in clinical studies?
Studies report effective reduction in hypertension and successful embolization outcomes, including complete occlusion in some cases.
What complications have been reported?
Safety data indicate risks of symptomatic embolism, heparinization-related complications, and potential hemorrhage.
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.