Temporary Coil Embolization Assist Device
The Temporary Coil Embolization Assist Device is a neurology prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils, delivered via an endovascular approach and removed from the body upon completion of the procedure. It is classified as FDA Class II under regulation 21 CFR 882.5955, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PUU and it falls under the Neurology medical specialty. It is not flagged as a permanent implant or life-sustaining device, as it is explicitly designed for temporary use.
Basic Information
- Product Code
- PUU
- Device Class
- FDA class 2
- Regulation Number
- 882.5955
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN170064 | Comaneci, Comaneci Petit, Comaneci 17 | Apr 24, 2019 | Unknown | Rapid-Medical , Ltd. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.