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U.S. Department of Health and Human Services

Product Classification

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Device temporary coil embolization assist device
Regulation Description Temporary coil embolization assist device.
Definition A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
Physical State The device is composed of a wire mesh stent permanently affixed to end the end of a pusher wire. Once in place the internal core wire with drawn distally which expands the mesh and blocks the neck of the aneurysm.
Technical Method The device acts as a temporary bridge used to aid in the coiling processes while minimizing the risk of coil protrusion or prolapse. Once the coiling procedure is completed the device is removed from the parent artery.
Target Area This device is used to treat intracranial aneurysms.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePUU
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5955
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible