COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK
Device Facts
| Record ID | K881330 |
|---|---|
| Device Name | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK |
| Applicant | Cobe Laboratories, Inc. |
| Product Code | DWF · Cardiovascular |
| Decision Date | Jun 10, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4210 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.
