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models 6207 6208 6209 6210 6211 6212 6214 pli s
Medtronic Vascular
Summary: The models 6207-6214 PLI S are embolization coils by Medtronic Vascular, primarily used for vascular embolization. FDA-cleared with evidence from 10 studies.
FDA Clearance Information
Pathway
510K
Number
K900515 ↗
Decision Date
August 23, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The models 6207-6214 PLI S were cleared via the FDA 510(k) pathway on August 23, 1990. Manufactured by Medtronic Vascular, they are classified as Class 2 devices.
What It Is
The models 6207-6214 PLI S are embolization coils designed for vascular embolization procedures. They are intended to occlude blood vessels to prevent blood flow to certain areas, often used in treating aneurysms or controlling bleeding.
Clinical Applications
These embolization coils are commonly used in interventional radiology for procedures such as treating cerebral aneurysms, gastrointestinal bleeding, and pre-surgical embolization of tumors.
Evidence Summary
The literature includes 10 studies, encompassing various study types such as RCTs and case series. The studies span from 2018 to 2024, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the models 6207-6214 PLI S are effective in achieving vascular occlusion with high success rates in embolization procedures. The coils demonstrate reliable performance in reducing blood flow to targeted areas, contributing to positive clinical outcomes.
Safety Profile
Reported complications include minor adverse events such as local inflammation and transient pain at the site of embolization. No major safety concerns have been consistently identified across the studies.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials specifically evaluating long-term outcomes. Further research is needed to assess the device's performance in diverse patient populations and complex clinical scenarios.
Frequently Asked Questions
What are the clinical indications for models 6207-6214 PLI S?
The models 6207-6214 PLI S are indicated for vascular embolization procedures, including treatment of aneurysms and controlling bleeding.
What outcomes have been reported in clinical studies?
Studies report effective vascular occlusion and high success rates in embolization procedures with these coils.
What complications have been reported?
Reported complications include minor adverse events such as local inflammation and transient pain.
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.