SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924
Device Facts
| Record ID | K010737 |
|---|---|
| Device Name | SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 |
| Applicant | Medtronic Cardiac Surgical Products |
| Product Code | DWF · Cardiovascular |
| Decision Date | Apr 4, 2001 |
| 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.
