Device |
embolization agent, vascular |
Definition |
For occluding peripheral vessels |
Physical State |
Injectable material(s) that forms (e.g., polymerizes, precipitates) in situ to obstruct blood flow. It is unlike the coil or particulate embolization devices in that it polymerizes in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations. |
Technical Method |
Material(s) delivered via catheter to the peripheral vessel to occlude the vessel and obstruct blood flow |
Target Area |
Peripheral vessels |
Review Panel |
Cardiovascular |
Product Code | QVG |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |