The following data is part of a premarket notification filed by Biotronik, Inc with the FDA for Biotronik Stylets.
| Device ID | K191469 |
| 510k Number | K191469 |
| Device Name: | Biotronik Stylets |
| Classification | Stylet, Catheter |
| 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 | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-03 |
| Decision Date | 2019-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035479000677 | K191469 | 000 |
| 04035479011864 | K191469 | 000 |
| 04035479011970 | K191469 | 000 |
| 04035479012083 | K191469 | 000 |
| 04035479007485 | K191469 | 000 |
| 04035479002022 | K191469 | 000 |
| 04035479018313 | K191469 | 000 |
| 04035479018337 | K191469 | 000 |
| 04035479047122 | K191469 | 000 |
| 04035479068400 | K191469 | 000 |
| 04035479071301 | K191469 | 000 |
| 04035479004385 | K191469 | 000 |
| 04035479100650 | K191469 | 000 |