Device |
sensor, pressure, aneurysm, implantable |
Regulation Description |
Implantable Intra-aneurysm Pressure Measurement System. |
Definition |
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure. |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | NQH |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
Submission Type |
510(k)
|
Regulation Number |
870.2855
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Guidance Documents
|
Third Party Review |
Not Third Party Eligible |