SWAN-GANZ HEPARIN COATED, ETC. CATHETER
Device Facts
| Record ID | K811411 |
|---|---|
| Device Name | SWAN-GANZ HEPARIN COATED, ETC. CATHETER |
| Applicant | American Edwards Laboratories |
| Product Code | KRB · Cardiovascular |
| Decision Date | Jun 12, 1981 |
| 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.