The following data is part of a premarket notification filed by Convatec, Inc. with the FDA for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus.
| Device ID | K221593 |
| 510k Number | K221593 |
| Device Name: | Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus |
| Classification | Catheter, Straight |
| Applicant | ConvaTec, Inc. 7815 National Service Road, Suite 600 Greensboro, NC 27409 |
| Contact | Courtney Smith |
| Correspondent | Dawn Norman MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-02 |
| Decision Date | 2022-11-17 |