| K-number | K971643 |
| Device name | RUSCH BRILLANT BALLOON CATHETER |
| Applicant | Rusch Intl. |
| Product code | EZL |
| Device class | Class II |
| Decision date | Oct 7, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 876.5130 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov