The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Trailrunner Guidewires.
| Device ID | K092965 |
| 510k Number | K092965 |
| Device Name: | TRAILRUNNER GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Karen Mortensen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-09-25 |
| Decision Date | 2010-02-26 |
| Summary: | summary |