The following data is part of a premarket notification filed by Dornier Medtech America Inc with the FDA for Equinox Balloon Dilatation Catheter.
| Device ID | K190612 |
| 510k Number | K190612 |
| Device Name: | EQUINOX Balloon Dilatation Catheter |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | Dornier MedTech America Inc 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer Dornier MedTech America Inc 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-11 |
| Decision Date | 2019-12-06 |