The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-coated Ureteric Catheters.
| Device ID | K171043 |
| 510k Number | K171043 |
| Device Name: | Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters |
| Classification | Catheter, Ureteral, Gastro-urology |
| 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 | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-07 |
| Decision Date | 2017-12-21 |
| Summary: | summary |