The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Safety Wire Guide Introducer.
| Device ID | K180756 |
| 510k Number | K180756 |
| Device Name: | Safety Wire Guide Introducer |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | COOK Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47404 |
| Contact | Carly Powell |
| Correspondent | Carly Powell COOK Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47404 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-05-24 |
| Summary: | summary |