Device Type ID | 774 |
Device Name | Clip, Vascular |
Regulation Description | Vascular Clip. |
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 | 870.3250 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DSS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 774 |
Device | Clip, Vascular |
Product Code | DSS |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Vascular Clip. |
CFR Regulation Number | 870.3250 [🔎] |
Device Problems | |
---|---|
Unintended Movement | 1 |
Break | 1 |
Total Device Problems | 2 |