EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116
Device Facts
| Record ID | K881449 |
|---|---|
| Device Name | EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 |
| Applicant | Baxter Healthcare Corp |
| Product Code | LXN · Cardiovascular |
| Decision Date | Jun 15, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4500 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.
