The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Galeo Hs 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo F 014 Model 115 487 Galeo Hf 018.
| Device ID | K982272 |
| 510k Number | K982272 |
| Device Name: | GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018 |
| Classification | Wire, Guide, Catheter |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | David Makanani |
| Correspondent | David Makanani BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-29 |
| Decision Date | 1999-01-08 |
| Summary: | summary |