The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets.
| Device ID | K211911 |
| 510k Number | K211911 |
| Device Name: | Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets |
| Classification | Catheter, Nephrostomy |
| Applicant | Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Angela Kilian |
| Correspondent | Angela Kilian Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2022-03-10 |