Definition: This Device Is Intended To Measure The Pressure In The Aneurysm Sac During And After An Endovascular Procedure.
Device Type ID | 919 |
Device Name | Sensor, Pressure, Aneurysm, Implantable |
Regulation Description | Implantable Intra-aneurysm Pressure Measurement System. |
Regulation Medical Specialty | Cardiovascular |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
Submission Type | 510(k) |
CFR Regulation Number | 870.2855 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NQH |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 919 |
Device | Sensor, Pressure, Aneurysm, Implantable |
Product Code | NQH |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Implantable Intra-aneurysm Pressure Measurement System. |
CFR Regulation Number | 870.2855 [🔎] |