The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Smarxt Optima Xp Surface Modified Hollow Fiber Membrane Oxygenator.
| Device ID | K000255 |
| 510k Number | K000255 |
| Device Name: | COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-28 |
| Decision Date | 2000-04-25 |