| Device |
immunoglobulin g (igg) infusion system |
| Regulation Description |
Infusion pump. |
| Definition |
An Immunoglobulin G (IgG) Infusion System is a prescription device intended for subcutaneous delivery of Immunoglobulin G (IgG) in accordance with the FDA approved labeling. |
| Physical State |
An Immunoglobulin G (IgG) infusion system includes the delivery device, reservoir or syringe, and any administration sets and / or subcutaneous catheters or needles to infuse Immunoglobulin G (IgG) into subcutaneous tissue. |
| Technical Method |
An Immunoglobulin G (IgG) infusion system infuses Immunoglobulin G (IgG) into subcutaneous tissue in accordance with FDA approved labeling. |
| Target Area |
In accordance with FDA approved labeling, an Immunoglobulin G (IgG) infusion system is for subcutaneous infusion only. |
| Regulation Medical Specialty |
General Hospital |
| Review Panel |
General Hospital |
|---|
| Product Code | PKP |
|---|
| 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 |
880.5725
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
