The following data is part of a premarket notification filed by Coloplast Corp with the FDA for In-ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath.
| Device ID | K201165 |
| 510k Number | K201165 |
| Device Name: | In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath |
| Classification | Catheter, Nephrostomy |
| Applicant | Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Cori Ragan |
| Correspondent | Sihem Darraji 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 | 2020-05-01 |
| Decision Date | 2020-12-17 |