The following data is part of a premarket notification filed by Lake Region Medical with the FDA for Enroute 0.014 Guidewire.
| Device ID | K160643 |
| 510k Number | K160643 |
| Device Name: | ENROUTE 0.014 Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MEDICAL PARKMORE W BUSINESS PARK Galway, IE G07001 |
| Contact | Michael Dunning |
| Correspondent | Michael Dunning LAKE REGION MEDICAL PARKMORE W BUSINESS PARK Galway, IE G07001 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-10-18 |
| Summary: | summary |