The following data is part of a premarket notification filed by Urogen Pharma Ltd. with the FDA for Urogen Ureteral Catheter.
| Device ID | K180354 |
| 510k Number | K180354 |
| Device Name: | UroGen Ureteral Catheter |
| Classification | Catheter, Urological |
| Applicant | UroGen Pharma Ltd. 9 Ha`Ta`asiya Street Ra’anana, IL 4365007 |
| Contact | James G. Ottinger |
| Correspondent | James G. Ottinger UroGen Pharma 499 Park Avenue, 12th Floor, Suite 1200 New York, NY 10022 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-08 |
| Decision Date | 2018-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854913006058 | K180354 | 000 |