The following data is part of a premarket notification filed by Coloplast with the FDA for Speedicath Flex Coude Pro.
| Device ID | K190620 |
| 510k Number | K190620 |
| Device Name: | SpeediCath Flex Coude Pro |
| Classification | Catheter, Urethral |
| Applicant | Coloplast 1601 West River Road North Minneapolis, MN 55411 |
| Contact | Delaney Mcdougal |
| Correspondent | Delaney Mcdougal Coloplast 1601 West River Road North Minneapolis, MN 55411 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-11 |
| Decision Date | 2019-07-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05708932125499 | K190620 | 000 |
| 05708932765497 | K190620 | 000 |
| 05708932765619 | K190620 | 000 |
| 05708932765893 | K190620 | 000 |
| 05708932125314 | K190620 | 000 |
| 05708932125352 | K190620 | 000 |
| 05708932125383 | K190620 | 000 |
| 05708932125413 | K190620 | 000 |
| 05708932125437 | K190620 | 000 |
| 05708932125468 | K190620 | 000 |
| 05708932766135 | K190620 | 000 |