COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
Device Facts
| Record ID | K002591 |
|---|---|
| Device Name | COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR |
| Applicant | Cobe Cardiovascular, Inc. |
| Product Code | DTP · Cardiovascular |
| Decision Date | Sep 13, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.4230 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass defoamer is a device used in conjunction with an oxygenator during cardiopulmonary bypass surgery to remove gas bubbles from the blood.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions.”
