PROBE & CATHETER
Device Facts
| Record ID | K771663 |
|---|---|
| Device Name | PROBE & CATHETER |
| Applicant | Edwards Laboratories |
| Product Code | KRB · Cardiovascular |
| Decision Date | Sep 20, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1915 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.