SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
Device Facts
| Record ID | K910429 |
|---|---|
| Device Name | SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER |
| Applicant | Baxter Healthcare Corp |
| Product Code | DXO · Cardiovascular |
| Decision Date | Jul 11, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2870 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.