The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Lunderquist Extra Stiff Wire Guide.
| Device ID | K220137 |
| 510k Number | K220137 |
| Device Name: | Lunderquist Extra Stiff Wire Guide |
| Classification | Wire, Guide, Catheter |
| Applicant | William Cook Europe ApS Sandet 6 Bjaeverskov, DK 4632 |
| Contact | Mie Dyrholm |
| Correspondent | Jennifer Brown William Cook Europe ApS Sandet 6 Bjaeverskov, DK 4632 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-18 |
| Decision Date | 2022-02-17 |