The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Malecot Nephrostomy Catheter/stent Set.
| Device ID | K180029 |
| 510k Number | K180029 |
| Device Name: | Malecot Nephrostomy Catheter/Stent Set |
| Classification | Stent, Ureteral |
| 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 | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-03 |
| Decision Date | 2018-09-21 |
| Summary: | summary |