Biotronik, Inc. · Class II · Cleared Nov 21, 2019
| K-number | K192996 |
| Device name | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool |
| Applicant | Biotronik, Inc. |
| Product code | DQY |
| Device class | Class II |
| Decision date | Nov 21, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 870.1250 |
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