POLYSTAN HEART LUNG MACHINE SYS
Device Facts
| Record ID | K813034 |
|---|---|
| Device Name | POLYSTAN HEART LUNG MACHINE SYS |
| Applicant | Advocacy International, Ltd. |
| Product Code | DTQ · Cardiovascular |
| Decision Date | Nov 27, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4220 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.
