PUU
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Temporary Coil Embolization Assist Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5955
- Medical specialty
- Neurology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Comaneci, Comaneci Petit, Comaneci 17 (DEN170064) | Rapid-Medical , Ltd. | 2019-04-24 |
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