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flipper detachable embolization coils
Cook
Summary: Flipper Detachable Embolization Coils are used for vascular embolization procedures. FDA cleared via 510k in 2006. Key studies explore imaging artifacts and occlusion methods.
FDA Clearance Information
Pathway
510K
Number
K063619 ↗
Decision Date
December 20, 2006
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The Flipper Detachable Embolization Coils by Cook were cleared by the FDA through the 510k pathway on December 20, 2006. They are classified as Class 2 under product code KRD.
What It Is
Flipper Detachable Embolization Coils are medical devices used in vascular embolization to occlude blood vessels. They are designed to be deployed within the vasculature to obstruct blood flow to a target area, aiding in the treatment of various vascular conditions.
Clinical Applications
These coils are commonly used in interventional radiology and cardiology for procedures such as treating aneurysms or controlling bleeding. They are particularly useful in scenarios requiring precise vascular occlusion.
Evidence Summary
The available literature includes two studies, one from 2013 and another from 2012. These studies encompass various methodologies, including prospective and retrospective analyses, focusing on imaging artifacts and occlusion methods.
Reported Outcomes
Published studies report on the effects of embolization coils on CMR images at different Tesla strengths and compare occlusion methods in canine models. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include potential imaging artifacts when used in conjunction with CMR, as noted in the study on pediatric cardiovascular devices. No specific adverse events are detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed efficacy and safety outcomes in human populations. Further research is needed to explore long-term outcomes and potential complications in clinical settings.
Frequently Asked Questions
What are the clinical indications for Flipper Detachable Embolization Coils?
The coils are indicated for vascular embolization procedures to occlude blood vessels in various clinical scenarios.
What outcomes have been reported in clinical studies?
Studies have reported on imaging artifacts and occlusion methods, but specific clinical efficacy outcomes are not detailed.
What complications have been reported?
Safety data indicates potential imaging artifacts with CMR, but no specific adverse events are detailed in the provided studies.
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.