The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Vortek Single Loop Ureteral Stent.
| Device ID | K201436 |
| 510k Number | K201436 |
| Device Name: | Vortek Single Loop Ureteral Stent |
| Classification | Stent, Ureteral |
| Applicant | Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Cori Ragan |
| Correspondent | Cori Ragan Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2021-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03600040910764 | K201436 | 000 |
| 03600040910924 | K201436 | 000 |
| 03600040910788 | K201436 | 000 |
| 03600040910894 | K201436 | 000 |
| 03600040910740 | K201436 | 000 |
| 03600040910856 | K201436 | 000 |
| 03600040910795 | K201436 | 000 |
| 03600040910726 | K201436 | 000 |
| 03600040910979 | K201436 | 000 |