The following data is part of a premarket notification filed by Lake Region Medical with the FDA for Pre-formed Guidewire.
| Device ID | K151244 |
| 510k Number | K151244 |
| Device Name: | Pre-Formed Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Lake Region Medical 340 Lake Hazeltine Dr. Chaska, MN 55318 |
| Contact | Mathew Pexa |
| Correspondent | Mathew Pexa Lake Region Medical 340 Lake Hazeltine Dr. Chaska, MN 55318 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-11 |
| Decision Date | 2015-06-11 |
| Summary: | summary |