SILICONE FLOW-DIRECTED THERMODILUTION CATHETER
Device Facts
| Record ID | K893435 |
|---|---|
| Device Name | SILICONE FLOW-DIRECTED THERMODILUTION CATHETER |
| Applicant | Cathlab Corp. |
| Product Code | DYG · Cardiovascular |
| Decision Date | Sep 26, 1989 |
| 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.
