K183051 is an FDA 510(k) clearance for the Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set. This device is classified as a Catheter, Nephrostomy.
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 16, 2019, 256 days after receiving the submission on November 2, 2018.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K183051 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | November 02, 2018 |
| Decision Date | July 16, 2019 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |