The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Angled Tip Ureteral Catheter.
| Device ID | K181144 |
| 510k Number | K181144 |
| Device Name: | Angled Tip Ureteral Catheter |
| Classification | Catheter, Urological |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Chelsea Woods |
| Correspondent | Chelsea Woods Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-01 |
| Decision Date | 2018-06-28 |
| Summary: | summary |