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detach 18 and detach 11 neurological embolization coil system
Cook
Summary: The Detach 18 and Detach 11 are neurological embolization coil systems used for embolization procedures. Cleared by the FDA via the 510(k) pathway, they are supported by 15 studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K000651 ↗
Decision Date
November 24, 2000
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Detach 18 and Detach 11 neurological embolization coil systems were cleared by the FDA through the 510(k) pathway on November 24, 2000. Manufactured by Cook, these devices are classified as Class 2 under product code HCG.
What It Is
The Detach 18 and Detach 11 are embolization coil systems designed for use in neurological procedures. They function by occluding blood vessels to prevent blood flow to certain areas, commonly used in the treatment of aneurysms or vascular malformations.
Clinical Applications
These embolization coils are typically used in interventional radiology and neurosurgery to treat cerebral aneurysms and arteriovenous malformations. They are deployed in scenarios where blood flow needs to be controlled or stopped to prevent rupture or bleeding.
Evidence Summary
The available literature consists of 15 studies, though the specific types and outcomes of these studies are not detailed in the provided evidence. The studies span various years, with some recent publications in 2023 and 2024.
Reported Outcomes
Published studies report limited specific outcomes related to the Detach 18 and Detach 11 systems. The evidence provided does not detail efficacy findings directly related to these devices, indicating a need for further specific research.
Safety Profile
Reported complications include limited safety data specific to the Detach 18 and Detach 11 systems. The evidence provided does not specify adverse events or complications, suggesting a gap in detailed safety reporting.
Evidence Limitations
The evidence lacks specific outcomes and safety data directly related to the Detach 18 and Detach 11 systems. Further research is needed to establish detailed efficacy and safety profiles, as current studies do not provide comprehensive insights.
Frequently Asked Questions
What are the clinical indications for Detach 18 and Detach 11?
The Detach 18 and Detach 11 are indicated for use in embolization procedures, particularly in treating cerebral aneurysms and arteriovenous malformations.
What outcomes have been reported in clinical studies?
Specific outcomes related to the Detach 18 and Detach 11 systems are not detailed in the provided evidence, indicating a need for further research.
What complications have been reported?
The provided evidence does not specify complications related to the Detach 18 and Detach 11 systems, highlighting a gap in safety data.
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.