The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Lunderquist Wire Guide; Dc Wire Guide.
| Device ID | K061670 |
| 510k Number | K061670 |
| Device Name: | LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE |
| Classification | Wire, Guide, Catheter |
| Applicant | WILLIAM COOK EUROPE APS SANDET 6, DK-4632 Bjaeverskov, DK |
| Contact | Tina H Anderson |
| Correspondent | Tina H Anderson WILLIAM COOK EUROPE APS SANDET 6, DK-4632 Bjaeverskov, DK |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-14 |
| Decision Date | 2007-01-19 |
| Summary: | summary |