PRESSURE CATHETER PLACEMENT SET 50010
Device Facts
| Record ID | K841482 |
|---|---|
| Device Name | PRESSURE CATHETER PLACEMENT SET 50010 |
| Applicant | Dlp, Inc. |
| Product Code | DWF · Cardiovascular |
| Decision Date | Jun 11, 1984 |
| 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.
