PUUClass II
Temporary Coil Embolization Assist Device
Neurology · 21 CFR 882.5955
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.
MDR events26All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances1All time
Recent MDR events
26 adverse event reports on file
- COMANECI 17Jul 20, 2026InjuryRapid-medical Ltd.3009957947-2026-00006
- COMANECI EMBOLIZATION ASSIST DEVICEJul 1, 2024InjuryRapid Medical Ltd3009957947-2024-00002
- COMANECI EMBOLIZATION ASSIST DEVICEJul 1, 2024InjuryRapid Medical Ltd3015531723-2024-00002
- COMANECI EMBOLIZATION ASSIST DEVICEApr 24, 2023InjuryRapid Medical Ltd.3015531723-2023-00007
- COMANECI EMBOLIZATION ASSIST DEVICEApr 20, 2023InjuryRapid Medical Ltd3009957947-2023-00007
- COMANECI 17Mar 27, 2023InjuryRapid Medical Ltd.3015531723-2023-00005
- COMANECI 17Mar 27, 2023InjuryRapid Medical Ltd.3015531723-2023-00006
- COMANECIFeb 16, 2023InjuryRapid-medical Ltd.3009957947-2023-00003
- COMANECI 17Jan 3, 2023InjuryRapid-medical Ltd3009957947-2023-00001
- COMANECI 17Jan 3, 2023InjuryRapid Medical Ltd.3015531723-2023-00001
Event type breakdown
Injury25
Malfunction1
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
1 clearances for this product code