| Device |
single lumen ecmo cannula |
| Regulation Description |
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. |
| Definition |
Single-lumen cannulas/catheters to be used with an extracorporeal circuit intended for use 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 |
A polymeric tube designed to fit the anatomy of several different arteries and/or veins for access to the circulatory system |
| Technical Method |
Acts as a conduit for blood flow between the patient's circulatory system and the extracorporeal circuit. |
| Target Area |
Major arteries/veins leading to/from the heart; some peripheral sites such as jugular or femoral. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QHW |
|---|
| 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? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
