The following data is part of a premarket notification filed by Coloplast with the FDA for Self-cath And Self-cath Plus.
| Device ID | K221401 |
| 510k Number | K221401 |
| Device Name: | Self-Cath And Self-Cath Plus |
| Classification | Catheter, Straight |
| Applicant | Coloplast 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Preeti Jain |
| Correspondent | Preeti Jain Coloplast 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-16 |
| Decision Date | 2022-12-02 |