The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Galeo Hydro And Galeo Hydro J-tip.
| Device ID | K001736 |
| 510k Number | K001736 |
| Device Name: | GALEO HYDRO AND GALEO HYDRO J-TIP |
| Classification | Wire, Guide, 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-07 |
| Decision Date | 2000-08-02 |