The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Ultraxx Nephrostomy Balloon Catheter.
| Device ID | K171601 |
| 510k Number | K171601 |
| Device Name: | Ultraxx Nephrostomy Balloon Catheter |
| Classification | Catheter, Nephrostomy |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Minjin Choi |
| Correspondent | Minjin Choi Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-01 |
| Decision Date | 2018-02-23 |
| Summary: | summary |