CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN
Device Facts
| Record ID | K853383 |
|---|---|
| Device Name | CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN |
| Applicant | Webster Laboratories, Inc. |
| Product Code | DYG · Cardiovascular |
| Decision Date | Dec 3, 1985 |
| 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.
