Definition: A Subcutaneous Implanted Apheresis Port Is A Prescription Device Intended For Patient Therapies Requiring Repeated Access To The Vascular System And Long-term Therapeutic Apheresis
| Device Type ID | 2755 |
| Device Name | Subcutaneous Implanted Apheresis Port |
| Physical State | A Subcutaneous Implanted Apheresis Port Includes The Port Body, Intravascular Catheter, And Over-the-needle I.V. Catheter For Port Access. |
| Technical Method | An Apheresis Port Is For Patient Therapies Requiring Repeated Access To The Vascular System. The Port System Can Be Used For The Infusion Of Medications, I.V. Fluids, Parenteral Nutrition Solutions, Blood And Blood Products, Withdrawal Of Blood And L |
| Target Area | In Accordance With FDA Approved Labeling, A Subcutaneous Implanted Apheresis Port Is A Prescription Device Intended For Patient Therapies Requiring Repeated Access To The Vascular System And Long-term Therapeutic Apheresis. |
| Regulation Description | Subcutaneous, Implanted, Intravascular Infusion Port And 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 | 880.5965 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2755 |
| Device | Subcutaneous Implanted Apheresis Port |
| Product Code | PTD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Subcutaneous, Implanted, Intravascular Infusion Port And Catheter. |
| CFR Regulation Number | 880.5965 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Infuse | 5 |
Appropriate Term/Code Not Available | 5 |
Restricted Flow Rate | 2 |
Suction Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Backflow | 1 |
| Total Device Problems | 15 |