K190612 is an FDA 510(k) clearance for the EQUINOX Balloon Dilatation Catheter. This device is classified as a Dilator, Catheter, Ureteral (Class II - Special Controls, product code EZN).
Submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on December 6, 2019, 270 days after receiving the submission on March 11, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5470.
| 510(k) Number | K190612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 2019 |
| Decision Date | December 06, 2019 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZN — Dilator, Catheter, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5470 |