The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Pantera Leo.
| Device ID | K163660 |
| 510k Number | K163660 |
| Device Name: | Pantera LEO |
| Classification | Catheters, Transluminal Coronary Angioplasty, 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 | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-27 |
| Decision Date | 2017-01-26 |
| Summary: | summary |