The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Kaye Nephrostomy Tamponade Balloon Catheter And Stent Set.
| Device ID | K183051 |
| 510k Number | K183051 |
| Device Name: | Kaye Nephrostomy Tamponade Balloon Catheter And Stent Set |
| Classification | Catheter, Nephrostomy |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Yan Li |
| Correspondent | Yan Li Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-07-16 |