The following data is part of a premarket notification filed by Coloplast Corp with the FDA for In-ka Ureteral Balloon Dilatation Catheter.
| Device ID | K201007 |
| 510k Number | K201007 |
| Device Name: | In-Ka Ureteral Balloon Dilatation Catheter |
| Classification | Dilator, Catheter, 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 | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-17 |
| Decision Date | 2020-06-11 |