The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Dual Lumen Ureteral Access Catheter, Flexi-tip Dual Lumen Ureteral Access Catheter.
| Device ID | K180182 |
| 510k Number | K180182 |
| Device Name: | Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Samuel Engelman |
| Correspondent | Samuel Engelman Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-23 |
| Decision Date | 2018-09-14 |
| Summary: | summary |