EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
Device Facts
| Record ID | K000274 |
|---|---|
| Device Name | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE |
| Applicant | Medtronic Cardiac Surgical Products |
| Product Code | DWF · Cardiovascular |
| Decision Date | Feb 10, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
