Definition: Access To Central Venous System For Blood Sampling And Infusion, And To Provide A Means To Secure The Catheter Via A Subcutaneous Anchor Below The Insertion Site.
| Device Type ID | 2715 |
| Device Name | Implanted Subcutaneous Securement Catheter |
| Physical State | Central Venous Catheter With Subcutaneous Securement System. |
| Technical Method | Central Venous Catheter With Subcutaneous Securement System. |
| Target Area | Vascular System, Subcutaneous Tissue. |
| Regulation Description | Percutaneous, Implanted, Long-term Intravascular Catheter. |
| Regulation Medical Specialty | General Hospital |
| 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) |
| CFR Regulation Number | 880.5970 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OKC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2715 |
| Device | Implanted Subcutaneous Securement Catheter |
| Product Code | OKC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous, Implanted, Long-term Intravascular Catheter. |
| CFR Regulation Number | 880.5970 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INTERRAD MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
No Apparent Adverse Event | 5 |
Adverse Event Without Identified Device Or Use Problem | 2 |
| Total Device Problems | 7 |