The following data is part of a premarket notification filed by Lake Region Medical with the FDA for Pre-formed Blue.
| Device ID | K221575 |
| 510k Number | K221575 |
| Device Name: | Pre-Formed Blue |
| Classification | Wire, Guide, Catheter |
| Applicant | Lake Region Medical 340 Lake Hazeltine Drive Chaska, MN 55318 |
| Contact | Deko Hussein |
| Correspondent | Deko Hussein Lake Region Medical 340 Lake Hazeltine Drive Chaska, MN 55318 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-01 |
| Decision Date | 2022-10-07 |