K201165 is an FDA 510(k) clearance for the In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath. This device is classified as a Catheter, Nephrostomy.
Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on December 17, 2020, 230 days after receiving the submission on May 1, 2020.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K201165 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | May 01, 2020 |
| Decision Date | December 17, 2020 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |