| Device |
subcutaneous implanted apheresis port |
| Regulation Description |
Subcutaneous, implanted, intravascular infusion port and catheter. |
| 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 |
| 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 long-term therapeutic apheresis. |
| 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 Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | PTD |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
880.5965
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
