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flipper detachable embolization coil
Cook
Summary: The Flipper Detachable Embolization Coil by Cook is used for embolization procedures. It is FDA 510k cleared with evidence from two studies focusing on its effects in interventional procedures.
FDA Clearance Information
Pathway
510K
Number
K993455 ↗
Decision Date
January 11, 2000
Product Code
KRD
Device Class
Class 2
Evidence
0 studies
The Flipper Detachable Embolization Coil was cleared by the FDA through the 510k pathway on January 11, 2000. It is manufactured by Cook and classified as a Class 2 device.
What It Is
The Flipper Detachable Embolization Coil is a medical device used in embolization procedures to occlude blood vessels. It is designed to be deployed within the vasculature to prevent blood flow to specific areas, aiding in the treatment of vascular abnormalities.
Clinical Applications
This device is commonly used in interventional radiology and cardiology to treat aneurysms, arteriovenous malformations, and other vascular conditions by occluding blood flow to targeted areas.
Evidence Summary
The available literature includes two studies published between 2012 and 2013. These studies are retrospective and case series in nature, focusing on the device's effects in interventional settings.
Reported Outcomes
Published studies report that the Flipper Detachable Embolization Coil is effective in occluding blood vessels during interventional procedures. The studies highlight its utility in both pediatric and veterinary settings, demonstrating successful outcomes in vascular occlusion.
Safety Profile
Reported complications include potential artifacts in CMR imaging at 1.5 T and 3 T, as noted in pediatric applications. No significant adverse events were highlighted in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Flipper Detachable Embolization Coil?
The device is indicated for use in embolization procedures to occlude blood vessels in conditions such as aneurysms and arteriovenous malformations.
What outcomes have been reported in clinical studies?
Studies report effective vascular occlusion in both pediatric and veterinary settings, with successful procedural outcomes.
What complications have been reported?
Safety data indicate potential CMR imaging artifacts, but no significant adverse events were reported in the studies provided.
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.