The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Vision Wire Coronary Guidewire.
| Device ID | K082935 |
| 510k Number | K082935 |
| Device Name: | VISION WIRE CORONARY GUIDEWIRE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-01 |
| Decision Date | 2008-12-04 |
| Summary: | summary |