CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
Device Facts
| Record ID | K003724 |
|---|---|
| Device Name | CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B |
| Applicant | Medtronic Vascular |
| Product Code | DTR · Cardiovascular |
| Decision Date | Dec 21, 2000 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.4240 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.
