The following data is part of a premarket notification filed by Dideco with the FDA for Monolyth Mimesys Hollow Fiber Oxygenator.
| Device ID | K004001 |
| 510k Number | K004001 |
| Device Name: | MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | DIDECO 14401 W. 65th Way Arvada, CO 80004 -3599 |
| Contact | Barbara Watson |
| Correspondent | Barbara Watson DIDECO 14401 W. 65th Way Arvada, CO 80004 -3599 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-10-04 |