The following data is part of a premarket notification filed by Lake Region Medical with the FDA for Anchorwire Guidewire.
| Device ID | K111288 |
| 510k Number | K111288 |
| Device Name: | ANCHORWIRE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | LAKE REGION MEDICAL 340 LAKE HAZELTINE DRIVE Chaska, MN 55318 |
| Contact | Mathew Pexa |
| 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 | 2011-05-06 |
| Decision Date | 2011-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447001010 | K111288 | 000 |
| 00685447001003 | K111288 | 000 |