The following data is part of a premarket notification filed by Coloplast with the FDA for Speedicath Flex Set.
| Device ID | K222059 |
| 510k Number | K222059 |
| Device Name: | SpeediCath Flex Set |
| 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 | 2022-07-13 |
| Decision Date | 2022-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05701780221559 | K222059 | 000 |
| 05701780221658 | K222059 | 000 |
| 05701780221641 | K222059 | 000 |
| 05701780221627 | K222059 | 000 |
| 05708932753081 | K222059 | 000 |
| 05708932755894 | K222059 | 000 |
| 05708932755870 | K222059 | 000 |
| 05708932755856 | K222059 | 000 |