The following data is part of a premarket notification filed by Urotronic Inc with the FDA for Optilume Basic Urological Balloon Dilation Catheter.
| Device ID | K191061 |
| 510k Number | K191061 |
| Device Name: | Optilume Basic Urological Balloon Dilation Catheter |
| Classification | Dilator, Urethral |
| Applicant | Urotronic Inc 2495 Xenium Lane N Minneapolis, MN 55441 |
| Contact | David Perry |
| Correspondent | Ming Cheng Chew Libra Medical 8401 73rd Ave N. Suite 63 Minneapolis, MN 55428 |
| Product Code | KOE |
| CFR Regulation Number | 876.5520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-22 |
| Decision Date | 2020-01-02 |