Peripheral Systems Group · Class II · Cleared Dec 27, 1991
| K-number | K913477 |
| Device name | APEX(TM) PROSTATIC BALLOON DILATION CATHETER |
| Applicant | Peripheral Systems Group |
| Product code | KOE |
| Device class | Class II |
| Decision date | Dec 27, 1991 |
| Decision | Substantially Equivalent |
| Regulation | 876.5520 |
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