The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Novoflow Reinforced Ureteral Stent.
| Device ID | K213186 |
| 510k Number | K213186 |
| Device Name: | NovoFlow Reinforced Ureteral Stent |
| Classification | Stent, Ureteral |
| Applicant | Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Gayatri Ghadge |
| Correspondent | Gayatri Ghadge Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2022-02-16 |