PUU — Temporary Coil Embolization Assist Device Class II
FDA product code PUU covers "Temporary Coil Embolization Assist Device", a Class II medical device regulated under 21 CFR 882.5955. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PUU
- Device Class
- Class II
- Regulation Number
- 882.5955
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170064 | rapid-medical | Comaneci, Comaneci Petit, Comaneci 17 | April 24, 2019 |