SWAN-GANZ FLOW-DIRECTED THERMODILUTION
Device Facts
| Record ID | K810352 |
|---|---|
| Device Name | SWAN-GANZ FLOW-DIRECTED THERMODILUTION |
| Applicant | American Edwards Laboratories |
| Product Code | DYG · Cardiovascular |
| Decision Date | Mar 27, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1240 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.
