MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
Device Facts
| Record ID | K853410 |
|---|---|
| Device Name | MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD |
| Applicant | Intermedics, Inc. |
| Product Code | DTR · Cardiovascular |
| Decision Date | Oct 11, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
