The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Optima And Cobe Cml Duo Membrane Oxygenators.
| Device ID | K964043 |
| 510k Number | K964043 |
| Device Name: | COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong 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 | 1996-10-09 |
| Decision Date | 1997-09-29 |
| Summary: | summary |