ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN
Device Facts
| Record ID | K850917 |
|---|---|
| Device Name | ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN |
| Applicant | Sherwood Medical Co. |
| Product Code | DWF · Cardiovascular |
| Decision Date | May 21, 1985 |
| 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.