The following data is part of a premarket notification filed by Biotronik, Inc with the FDA for Selectra 3d Outer Guiding Catheters.
| Device ID | K193474 |
| 510k Number | K193474 |
| Device Name: | Selectra 3D Outer Guiding Catheters |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035479176242 | K193474 | 000 |
| 04035479162061 | K193474 | 000 |
| 04035479162078 | K193474 | 000 |
| 04035479162085 | K193474 | 000 |
| 04035479162092 | K193474 | 000 |
| 04035479162108 | K193474 | 000 |
| 07640130455399 | K193474 | 000 |
| 07640130455405 | K193474 | 000 |
| 07640130455412 | K193474 | 000 |
| 04035479176228 | K193474 | 000 |
| 04035479176235 | K193474 | 000 |
| 04035479162054 | K193474 | 000 |