Device |
device, neurovascular embolization |
Regulation Description |
Neurovascular embolization device. |
Regulation Medical Specialty |
Neurology |
Review Panel |
Neurology |
Product Code | HCG |
Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
Submission Type |
510(k)
|
Regulation Number |
882.5950
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Guidance Documents
|
Third Party Review |
Not Third Party Eligible |
|
|