| Device |
thrombectomy whole blood return system |
| Regulation Description |
Autotransfusion apparatus. |
| Definition |
Filtration and return of aspirated whole blood during a thrombectomy procedure |
| Physical State |
The thrombectomy whole blood return system is a stand alone device intended for use with a specific thrombectomy system. Although the specific system components can vary, these thrombectomy whole blood return systems are comprised of a blood reservoir with a filter (usually at least 40 micron size) to filter out clot and other debris; tubing, a transfusion filter, and a syringe to transfer the filtered whole blood from the reservoir to the patient (through the transfusion filter). |
| Technical Method |
Blood and clot are aspirated via a thrombectomy catheter, filtered with the related blood return system and returned to the same patient at the point of care. |
| Target Area |
Any appropriate blood return site |
| Regulation Medical Specialty |
Anesthesiology |
| Review Panel |
Cardiovascular |
|---|
| Product Code | SHJ |
|---|
| Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
868.5830
|
|---|
| 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 |
