The following data is part of a premarket notification filed by Biotronik, Inc with the FDA for Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool.
| Device ID | K192996 |
| 510k Number | K192996 |
| Device Name: | Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool |
| Classification | Catheter, Percutaneous |
| Applicant | Biotronik, Inc 6024 Jean Road Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh Biotronik, Inc 6024 Jean Road Lake Oswego, OR 97035 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-28 |
| Decision Date | 2019-11-21 |