| Device |
blood pump for ecmo, long-term (> 6 hours) use |
| Regulation Description |
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. |
| Definition |
A blood pump for long-term circulatory support is a device intended for use as part of an extracorporeal circuit intended to provide assisted extracorporeal circulation and physiologic gas exchange of the patient's blood in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent. |
| Physical State |
Consists of metal rollers and plastic tubing (roller pumps), or a plastic centrifugal pump head and controller (non-roller type blood pumps); or a displacement pump (non-roller type blood pump). |
| Technical Method |
Roller or non-roller mechanisms are used to propel the patient's blood through the extracorporeal circuit to maintain a blood flow to sustain life. |
| Target Area |
Intended for use with other components of an extracorporeal circuit, including an oxygenator, to circulate and oxygenate a patient's entire blood volume for long durations (>6 hours). |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QNR |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.4100
|
|---|
| 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? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
