Device Type ID | 2853 |
Device Name | Port & Catheter, Implanted, Subcutaneous, Intraperitoneal |
Review Panel | General Hospital |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
Submission Type | 510(k) |
FDA Device Classification | Class Unclassified Medical Device |
Product Code | LLD |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2853 |
Device | Port & Catheter, Implanted, Subcutaneous, Intraperitoneal |
Product Code | LLD |
Device Problems | |
---|---|
Failure To Discharge | 1 |
Total Device Problems | 1 |