OEU · Cardiopulmonary Bypass Catheter Kit
Cardiovascular · 21 CFR 870.4210 · Class 2
Overview
| Product Code | OEU |
|---|---|
| Device Name | Cardiopulmonary Bypass Catheter Kit |
| Regulation | 21 CFR 870.4210 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
