The following data is part of a premarket notification filed by Dornier Medtech America Inc with the FDA for Dornier Minnow Ureteral Catheter.
| Device ID | K191187 |
| 510k Number | K191187 |
| Device Name: | Dornier MINNOW Ureteral Catheter |
| Classification | Catheter, Ureteral, Gastro-urology |
| 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 | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-03 |
| Decision Date | 2019-09-18 |
| Summary: | summary |