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 |