| Device |
combination compression/decompression manual chest pump with impedance respiratory valve |
| Definition |
Intended for use as a CPR adjunct to improve the likelihood of survival in adult patients with non-traumatic cardiac arrest. |
| Physical State |
The device system is comprised of two components: A manual pump containing a suction cup so that active decompression can take place. The valve is inserted in the respiratory circuit (e.g., facemask or advanced airway) during CPR. |
| Technical Method |
Uses active compression and decompression of the victim's chest during manual CPR, as well as impeding the inflow of air during the decompression phase to reduce the intrathoracic pressure and increase blood flow. |
| Target Area |
The pump is placed on the victim's chest, and the valve is placed within the respiratory circuit. |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PIZ |
|---|
| Premarket Review |
Circulatory Support, Structural and Vascular Devices
(DHT2B)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
